Actively Recruiting
Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome
Led by DalCor Pharmaceuticals · Updated on 2026-01-07
2000
Participants Needed
223
Research Sites
N/A
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
Researchers are studying the effects of dalcetrapib on cardiovascular risk in people who were recently hospitalized for acute coronary syndrome (ACS) and have a specific genetic profile (AA genotype). This phase 3, randomized, double-blind, placebo-controlled study aims to understand how this drug may impact the risk of heart-related events in this group. Participants will be screened based on their medical history and genetic testing to confirm eligibility. Participants will be randomly assigned to receive either dalcetrapib 600 mg daily (two 300 mg tablets) or matching placebo tablets once a day. The study will continue until about 200 participants have experienced a primary cardiovascular event or until a planned interim analysis stops the trial. After randomization, follow-up visits will occur every three months, often virtually when possible. During the study, participants will be monitored through medical assessments, including genetic testing, and virtual or clinic visits every three months. Researchers will measure the time to the first fatal or non-fatal heart attack over an average of 30 months from randomization. Secondary measures include death, cardiac arrest, stroke, and heart attacks. If a participant stops taking the study medication early, assessments will continue every three months to collect important study data.
CONDITIONS
Brief Title
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects recently hospitalized for acute coronary syndrome within 3 months of the event
- Both male and female subjects aged 45 years and older at screening
- AA genotype at variant gene confirmed by Genotype Assay Test
- Clinically stable, free of ischemic symptoms at rest or with minimal exertion for at least 1 week before randomization
- Evidence of guidelines-based LDL cholesterol management including medical and dietary treatment
- Randomization occurs within 3 months of the index acute coronary syndrome event
You will not qualify if you...
- Pregnant or breastfeeding females (negative pregnancy test required for women of child-bearing potential)
- Women of childbearing potential not using at least one highly effective contraception method
- New York Heart Association Class III or IV heart failure
- Acute coronary syndrome event caused by uncontrolled hypertension
- Systolic blood pressure over 180 mmHg and/or diastolic blood pressure over 110 mmHg at randomization despite treatment
- Clinically apparent liver disease or elevated liver enzymes above 3 times the upper limit of normal within 6 months prior to randomization
- History of unexplained high creatine phosphokinase levels (above 5 times upper limit of normal) within 6 months prior to randomization
- Estimated glomerular filtration rate less than 30 mL/min/1.73m2 within 6 months prior to randomization
- History of malignancy or other serious illness likely to interfere with study or life expectancy less than 3 years
- Laboratory values that may limit successful study participation as judged by investigator
- Use of investigational drugs within 1 month before randomization or participation in another investigational study during this trial
- Underwent coronary artery bypass graft surgery between the index event and randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 30 months from randomization
Participants take Dalcetrapib or matching placebo tablets daily to evaluate effects on cardiovascular risk after a recent acute coronary syndrome.
Virtual or clinic visits every 3 months until the study is stopped
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
Research Team
D
David Kallend, MBBS
T
Therese Heinonen, DVM
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here