Actively Recruiting

Phase 3
Age: 45Years +
All Genders
NCT05918861

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

Led by DalCor Pharmaceuticals · Updated on 2026-01-07

2000

Participants Needed

223

Research Sites

199 weeks

Total Duration

On this page

Sponsors

D

DalCor Pharmaceuticals

Lead Sponsor

T

The Montreal Health Innovations Coordinating Center (MHICC)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

CONDITIONS

Official Title

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

Who Can Participate

Age: 45Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 45 years and older
  • Recently hospitalized for acute coronary syndrome within 3 months of the event
  • Have the AA genotype at the ADCY9 gene variant confirmed by genotype testing
  • Clinically stable with no ischemic symptoms at rest or minimal exertion for at least 1 week before randomization
  • Receiving guideline-based management of LDL cholesterol including medical and dietary treatment
  • Able to be randomized within 3 months of the acute coronary syndrome event
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Women of childbearing potential not using at least one highly effective method of contraception
  • New York Heart Association (NYHA) Class III or IV heart failure
  • Acute coronary syndrome event caused by uncontrolled hypertension
  • Systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg at randomization despite treatment
  • Clinically apparent liver disease or elevated liver enzymes (ALT or AST >3 times upper limit) within 6 months prior to randomization
  • History of unexplained high creatine phosphokinase levels (>5 times upper limit) within 6 months prior to randomization
  • Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73m2 within 6 months prior to randomization
  • History of cancer or other serious illness likely to interfere with study participation or life expectancy less than 3 years
  • Any laboratory value that might limit successful participation as judged by the investigator
  • Received any investigational drug within 1 month prior to randomization or plans to participate in other investigational studies during this trial
  • Underwent coronary artery bypass graft surgery between the acute event and randomization

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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3
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Trial Site Locations

Total: 223 locations

1

Research Site

Alexander City, Alabama, United States, 35010

Withdrawn

2

Research Site

Birmingham, Alabama, United States, 35211

Actively Recruiting

3

Research Site

Fairhope, Alabama, United States, 36532

Actively Recruiting

4

Research Site

Huntsville, Alabama, United States, 35801

Actively Recruiting

5

Research Site

Mobile, Alabama, United States, 36608

Actively Recruiting

6

Research Site

Scottsdale, Arizona, United States, 85258

Actively Recruiting

7

Research Site

Tucson, Arizona, United States, 85724

Actively Recruiting

8

Research Site

Jonesboro, Arkansas, United States, 72405

Withdrawn

9

Research Site

North Little Rock, Arkansas, United States, 72117

Actively Recruiting

10

Research Site

Garden Grove, California, United States, 92844

Withdrawn

11

Research Site

Huntington Beach, California, United States, 92648

Actively Recruiting

12

Research Site

La Jolla, California, United States, 92037

Actively Recruiting

13

Research Site

Long Beach, California, United States, 90813

Withdrawn

14

Research Site

Los Angeles, California, United States, 90025

Withdrawn

15

Research Site

Newport Beach, California, United States, 92648

Not Yet Recruiting

16

Research Site

Newport Beach, California, United States, 92658

Not Yet Recruiting

17

Research Site

San Francisco, California, United States, 94143

Actively Recruiting

18

Research Site

Santa Barbara, California, United States, 93105

Actively Recruiting

19

Research Site

Stanford, California, United States, 94305

Actively Recruiting

20

Research Site

Torrance, California, United States, 90502

Actively Recruiting

21

Research Site

West Hills, California, United States, 91307

Actively Recruiting

22

Research Site

Aurora, Colorado, United States, 80011

Actively Recruiting

23

Research Site

Golden, Colorado, United States, 80401

Actively Recruiting

24

Research Site

Hartford, Connecticut, United States, 06102

Actively Recruiting

25

Research Site

New Haven, Connecticut, United States, 06519

Actively Recruiting

26

Research Site

Newark, Delaware, United States, 19718

Actively Recruiting

27

Research Site

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

28

Research Site

Washington D.C., District of Columbia, United States, 20060

Not Yet Recruiting

29

Research Site

Boca Raton, Florida, United States, 33434

Withdrawn

30

Research Site

Boca Raton, Florida, United States, 33486

Actively Recruiting

31

Research Site

Clearwater, Florida, United States, 33756

Actively Recruiting

32

Research Site

Doral, Florida, United States, 33166

Not Yet Recruiting

33

Research Site

Fort Lauderdale, Florida, United States, 33316

Actively Recruiting

34

Research Site

Fort Myers, Florida, United States, 33908

Actively Recruiting

35

Research Site

Gainesville, Florida, United States, 32608

Not Yet Recruiting

36

Research Site

Hialeah, Florida, United States, 33013

Withdrawn

37

Research Site

Homestead, Florida, United States, 33030

Actively Recruiting

38

Research Site

Jacksonville, Florida, United States, 32209

Actively Recruiting

39

Research Site

Kissimmee, Florida, United States, 34741

Withdrawn

40

Research Site

Largo, Florida, United States, 33777

Actively Recruiting

41

Research Site

Miami, Florida, United States, 33032

Actively Recruiting

42

Research Site

Miami, Florida, United States, 33033

Withdrawn

43

Research Site

Miami, Florida, United States, 33136

Actively Recruiting

44

Research Site

Miami, Florida, United States, 33145

Actively Recruiting

45

Research Site

Miami, Florida, United States, 33175

Withdrawn

46

Research Site

Miami Lakes, Florida, United States, 33014

Actively Recruiting

47

Research Site

Miami Lakes, Florida, United States, 33016

Actively Recruiting

48

Research Site

Ocala, Florida, United States, 34471

Actively Recruiting

49

Research Site

Pembroke Pines, Florida, United States, 33024

Withdrawn

50

Research Site

Pensacola, Florida, United States, 32502

Not Yet Recruiting

51

Research Site

Port Charlotte, Florida, United States, 33952

Actively Recruiting

52

Research Site

Safety Harbor, Florida, United States, 34695

Actively Recruiting

53

Research Site

Sarasota, Florida, United States, 34239

Actively Recruiting

54

Research Site

Tallahassee, Florida, United States, 32308

Actively Recruiting

55

Research Site

Tampa, Florida, United States, 33606

Actively Recruiting

56

Research Site

Tampa, Florida, United States, 33607

Actively Recruiting

57

Research Site

Winter Haven, Florida, United States, 33881

Actively Recruiting

58

Research Site

Acworth, Georgia, United States, 30101

Withdrawn

59

Research Site

Atlanta, Georgia, United States, 30310

Actively Recruiting

60

Research Site

Atlanta, Georgia, United States, 30322

Actively Recruiting

61

Research Site

Augusta, Georgia, United States, 30912

Not Yet Recruiting

62

Research Site

Gainesville, Georgia, United States, 30501

Not Yet Recruiting

63

Research Site

McDonough, Georgia, United States, 30253

Actively Recruiting

64

Research Site

Arlington Heights, Illinois, United States, 60005

Actively Recruiting

65

Research Site

Bloomingdale, Illinois, United States, 60108

Withdrawn

66

Research Site

Chicago, Illinois, United States, 60612

Not Yet Recruiting

67

Research Site

Chicago, Illinois, United States, 60616

Actively Recruiting

68

Research Site

Glenview, Illinois, United States, 60026

Actively Recruiting

69

Research Site

Hazel Crest, Illinois, United States, 60429

Withdrawn

70

Research Site

Park Ridge, Illinois, United States, 60068

Withdrawn

71

Research Site

Springfield, Illinois, United States, 62702

Actively Recruiting

72

Research Site

Fort Wayne, Indiana, United States, 46845

Actively Recruiting

73

Research Site

Indianapolis, Indiana, United States, 46202

Actively Recruiting

74

Research Site

Merrillville, Indiana, United States, 46410

Actively Recruiting

75

Research Site

Munster, Indiana, United States, 46321

Actively Recruiting

76

Research Site

Newburgh, Indiana, United States, 47630

Actively Recruiting

77

Research Site

Richmond, Indiana, United States, 47374

Actively Recruiting

78

Research Site

Davenport, Iowa, United States, 52801

Actively Recruiting

79

Research Site

Iowa City, Iowa, United States, 52242

Actively Recruiting

80

Research Site

West Des Moines, Iowa, United States, 50266

Actively Recruiting

81

Research Site

Kansas City, Kansas, United States, 66160

Actively Recruiting

82

Research Site

Edgewood, Kentucky, United States, 41017

Not Yet Recruiting

83

Research Site

Lexington, Kentucky, United States, 40536

Actively Recruiting

84

Research Site

Louisville, Kentucky, United States, 40202

Withdrawn

85

Research Site

Hammond, Louisiana, United States, 70403

Actively Recruiting

86

Research Site

Lafayette, Louisiana, United States, 70503

Actively Recruiting

87

Research Site

Mandeville, Louisiana, United States, 70448

Withdrawn

88

Research Site

New Orleans, Louisiana, United States, 70121

Actively Recruiting

89

Research Site

Bangor, Maine, United States, 04401

Actively Recruiting

90

Research Site

Baltimore, Maryland, United States, 21215

Actively Recruiting

91

Research Site

Bethesda, Maryland, United States, 20814

Actively Recruiting

92

Research Site

Bowie, Maryland, United States, 20715

Withdrawn

93

Research Site

Columbia, Maryland, United States, 21044

Actively Recruiting

94

Research Site

Nottingham, Maryland, United States, 21236

Actively Recruiting

95

Research Site

Bay City, Michigan, United States, 48708

Actively Recruiting

96

Research Site

Dearborn, Michigan, United States, 48126

Actively Recruiting

97

Research Site

Detroit, Michigan, United States, 48202

Actively Recruiting

98

Research Site

Kalamazoo, Michigan, United States, 49048

Not Yet Recruiting

99

Research Site

Midland, Michigan, United States, 48670

Actively Recruiting

100

Research Site

Mount Clemens, Michigan, United States, 48043

Not Yet Recruiting

101

Research Site

Petoskey, Michigan, United States, 49770

Actively Recruiting

102

Research Site

Traverse City, Michigan, United States, 49684

Not Yet Recruiting

103

Research Site

Ypsilanti, Michigan, United States, 48197

Actively Recruiting

104

Research Site

Coon Rapids, Minnesota, United States, 55433

Not Yet Recruiting

105

Research Site

Duluth, Minnesota, United States, 55805

Withdrawn

106

Research Site

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

107

Research Site

Minneapolis, Minnesota, United States, 55417

Actively Recruiting

108

Research Site

Saint Cloud, Minnesota, United States, 56303

Actively Recruiting

109

Research Site

Tupelo, Mississippi, United States, 38801

Actively Recruiting

110

Research Site

Springfield, Missouri, United States, 65804

Actively Recruiting

111

Research Site

St Louis, Missouri, United States, 63103

Not Yet Recruiting

112

Research Site

St Louis, Missouri, United States, 63110

Actively Recruiting

113

Research Site

St Louis, Missouri, United States, 63136

Actively Recruiting

114

Research Site

Lincoln, Nebraska, United States, 68506

Withdrawn

115

Research Site

Omaha, Nebraska, United States, 68124

Actively Recruiting

116

Research Site

Las Vegas, Nevada, United States, 89102

Actively Recruiting

117

Research Site

Bridgewater, New Jersey, United States, 08807

Actively Recruiting

118

Research Site

Hackensack, New Jersey, United States, 07601

Actively Recruiting

119

Research Site

Pomona, New Jersey, United States, 08240

Actively Recruiting

120

Research Site

Albuquerque, New Mexico, United States, 87102

Actively Recruiting

121

Research Site

Albany, New York, United States, 12211

Actively Recruiting

122

Research Site

Buffalo, New York, United States, 14203

Actively Recruiting

123

Research Site

Johnson City, New York, United States, 13790

Actively Recruiting

124

Research Site

New York, New York, United States, 10028

Actively Recruiting

125

Research Site

Poughkeepsie, New York, United States, 12601

Actively Recruiting

126

Research Site

Staten Island, New York, United States, 10310

Actively Recruiting

127

Research Site

Stony Brook, New York, United States, 11794

Actively Recruiting

128

Research Site

The Bronx, New York, United States, 10467

Not Yet Recruiting

129

Research Site

Pinehurst, North Carolina, United States, 28374

Withdrawn

130

Research Site

Rocky Mount, North Carolina, United States, 27804

Actively Recruiting

131

Research Site

Sanford, North Carolina, United States, 27330

Not Yet Recruiting

132

Research Site

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

133

Research Site

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

134

Research Site

Canton, Ohio, United States, 44710

Actively Recruiting

135

Research Site

Cincinnati, Ohio, United States, 45219

Withdrawn

136

Research Site

Cleveland, Ohio, United States, 44106

Actively Recruiting

137

Research Site

Springfield, Ohio, United States, 45504

Actively Recruiting

138

Research Site

Toledo, Ohio, United States, 43608

Actively Recruiting

139

Research Site

Allentown, Pennsylvania, United States, 18013

Not Yet Recruiting

140

Research Site

Allentown, Pennsylvania, United States, 18103

Actively Recruiting

141

Research Site

Chambersburg, Pennsylvania, United States, 17201

Actively Recruiting

142

Research Site

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

143

Research Site

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

144

Research Site

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

145

Research Site

West Reading, Pennsylvania, United States, 19611

Actively Recruiting

146

Research Site

Wyomissing, Pennsylvania, United States, 19610

Actively Recruiting

147

Research Site

Providence, Rhode Island, United States, 02906

Not Yet Recruiting

148

Research Site

Rock Hill, South Carolina, United States, 29732

Actively Recruiting

149

Research Site

Spartanburg, South Carolina, United States, 29303

Actively Recruiting

150

Research Site

Rapid City, South Dakota, United States, 57701

Actively Recruiting

151

Research Site

Chattanooga, Tennessee, United States, 37403

Not Yet Recruiting

152

Research Site

Greeneville, Tennessee, United States, 37745

Actively Recruiting

153

Research Site

Jefferson City, Tennessee, United States, 37760

Actively Recruiting

154

Research Site

Memphis, Tennessee, United States, 38120

Actively Recruiting

155

Research Site

Oak Ridge, Tennessee, United States, 37830

Actively Recruiting

156

Research Site

Powell, Tennessee, United States, 37849

Actively Recruiting

157

Research Site

Amarillo, Texas, United States, 79106

Actively Recruiting

158

Research Site

Beaumont, Texas, United States, 77702

Actively Recruiting

159

Research Site

Corpus Christi, Texas, United States, 78404

Actively Recruiting

160

Research Site

Cypress, Texas, United States, 77429

Actively Recruiting

161

Research Site

Dallas, Texas, United States, 75216

Actively Recruiting

162

Research Site

Dallas, Texas, United States, 75235

Actively Recruiting

163

Research Site

Houston, Texas, United States, 77030-1503

Not Yet Recruiting

164

Research Site

Houston, Texas, United States, 77070

Actively Recruiting

165

Research Site

Houston, Texas, United States, 77089

Actively Recruiting

166

Research Site

Houston, Texas, United States, 77090

Actively Recruiting

167

Research Site

Kingwood, Texas, United States, 77339

Actively Recruiting

168

Research Site

McKinney, Texas, United States, 75071

Actively Recruiting

169

Research Site

Mesquite, Texas, United States, 75149

Withdrawn

170

Research Site

Port Arthur, Texas, United States, 77642

Actively Recruiting

171

Research Site

San Antonio, Texas, United States, 78207

Not Yet Recruiting

172

Research Site

Victoria, Texas, United States, 77901

Actively Recruiting

173

Research Site

Waco, Texas, United States, 76712

Actively Recruiting

174

Research Site

Newport News, Virginia, United States, 23606

Withdrawn

175

Research Site

Norfolk, Virginia, United States, 23504

Actively Recruiting

176

Research Site

Richmond, Virginia, United States, 23219

Actively Recruiting

177

Research Site

Winchester, Virginia, United States, 22601

Actively Recruiting

178

Research Site

Seattle, Washington, United States, 98122

Actively Recruiting

179

Research Site

Calgary, Alberta, Canada, T1Y0B4

Withdrawn

180

Research Site

Edmonton, Alberta, Canada, T6G2B7

Actively Recruiting

181

Research Site

Abbotsford British Columbia, British Columbia, Canada, V2S 0C2

Actively Recruiting

182

Research Site

Burnaby, British Columbia, Canada, V5G 2X6

Actively Recruiting

183

Research Site

Kamloops, British Columbia, Canada, V2C2T1

Actively Recruiting

184

Research Site

North Vancouver, British Columbia, Canada, V7M 2H4

Withdrawn

185

Research Site

Vancouver, British Columbia, Canada, V5Z 1M9

Not Yet Recruiting

186

Research Site

Victoria, British Columbia, Canada, V8R 1B2

Withdrawn

187

Research Site

Winnipeg, Manitoba, Canada, R2H 2A6

Actively Recruiting

188

Research Site

Moncton, New Brunswick, Canada, E1C 2Z3

Actively Recruiting

189

Research Site

Moncton, New Brunswick, Canada, E1G 1A7

Actively Recruiting

190

Research Site

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Withdrawn

191

Research Site

Halifax, Nova Scotia, Canada, B3H3A7

Actively Recruiting

192

Research Site

Brampton, Ontario, Canada, L6R3J7

Not Yet Recruiting

193

Research Site

Cambridge, Ontario, Canada, N1R 6V6

Actively Recruiting

194

Research Site

Kingston, Ontario, Canada, K7L2V7

Actively Recruiting

195

Research Site

London, Ontario, Canada, N6A 5A5

Actively Recruiting

196

Research Site

Newmarket, Ontario, Canada, L3Y 2R2

Actively Recruiting

197

Research Site

Ottawa, Ontario, Canada, K1Y4W7

Not Yet Recruiting

198

Research Site

Scarborough Village, Ontario, Canada, M1B 4Z8

Actively Recruiting

199

Research Site

Scarborough Village, Ontario, Canada, M1B 5N1

Actively Recruiting

200

Research Site

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

201

Research Site

Toronto, Ontario, Canada, M5B 1W8

Not Yet Recruiting

202

Research Site

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

203

Research Site

Chicoutimi, Quebec, Canada, G7H 7K9

Withdrawn

204

Research Site

Granby, Quebec, Canada, J2G 1T7

Actively Recruiting

205

Research Site

Greenfield Park, Quebec, Canada, J4V 2H1

Actively Recruiting

206

Research Site

Laval, Quebec, Canada, H7M 3L9

Withdrawn

207

Research Site

Lévis, Quebec, Canada, G6V 9H4

Actively Recruiting

208

Research Site

Montreal, Quebec, Canada, H1T1C8

Actively Recruiting

209

Research Site

Montreal, Quebec, Canada, H2X 0C1

Actively Recruiting

210

Research Site

Montreal, Quebec, Canada, H3G1A4

Actively Recruiting

211

Research Site

Montreal, Quebec, Canada, H4J 1C5

Actively Recruiting

212

Research Site

Québec, Quebec, Canada, G1R 2J6

Actively Recruiting

213

Research Site

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

214

Research Site

Rimouski, Quebec, Canada, G5L5T1

Actively Recruiting

215

Research Site

Saint-Charles-Borromée, Quebec, Canada, J6E 6J2

Actively Recruiting

216

Research Site

Saint-Hubert, Quebec, Canada, J3Z 0C8

Actively Recruiting

217

Research Site

Saint-Jérôme, Quebec, Canada, J7Z 2V4

Actively Recruiting

218

Research Site

Terrebonne, Quebec, Canada, J6V 2H2

Actively Recruiting

219

Research Site

Trois-Rivières, Quebec, Canada, G8Z 3R9

Actively Recruiting

220

Research Site

Sherbrooke, Quebec City, Canada, J1H5N4

Actively Recruiting

221

Research Site

Saskatoon, Saskatchewan, Canada, S7N 0W8

Not Yet Recruiting

222

Research Site

Caguas, Puerto Rico, Puerto Rico, 00726

Withdrawn

223

Research Site

Carolina, Puerto Rico, 00984

Withdrawn

Loading map...

Research Team

D

David Kallend, MBBS

CONTACT

T

Therese Heinonen, DVM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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