Actively Recruiting

Phase 2
Age: 50Years - 80Years
All Genders
NCT05646381

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Led by Novartis Pharmaceuticals · Updated on 2026-04-15

502

Participants Needed

139

Research Sites

313 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

CONDITIONS

Official Title

A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

Who Can Participate

Age: 50Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 50 to under 80 years
  • Lipoprotein(a) level of 175 nmol/L or higher at screening
  • Diagnosis of mild or moderate calcific aortic valve stenosis
  • Optimally treated for existing cardiovascular risk factors at randomization
Not Eligible

You will not qualify if you...

  • Severe calcific aortic valve stenosis
  • Uncontrolled hypertension
  • History of any malignancy
  • History of hemorrhagic stroke or major bleeding
  • Platelet count below the lower limit of normal
  • Active liver disease or liver dysfunction
  • Significant kidney disease
  • Pregnant or nursing women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 139 locations

1

Heart Center Research Llc

Huntsville, Alabama, United States, 35801

Actively Recruiting

2

Cardiovascular Res Found

Beverly Hills, California, United States, 90210

Actively Recruiting

3

National Heart Institute

Beverly Hills, California, United States, 90211

Actively Recruiting

4

Flourish Clinical Resrch Covin

Covina, California, United States, 91723

Actively Recruiting

5

Valley Clinical Trials

Northridge, California, United States, 91325

Actively Recruiting

6

Stanford University Medical Center

Palo Alto, California, United States, 94304

Actively Recruiting

7

University Of California San Diego

San Diego, California, United States, 92103-8415

Actively Recruiting

8

UC San Francisco Medical Center

San Francisco, California, United States, 94143

Actively Recruiting

9

Excel Medical Clinical Trials LLC

Boca Raton, Florida, United States, 33434

Withdrawn

10

Nova Clinical Research LLC

Bradenton, Florida, United States, 34209

Actively Recruiting

11

Flourish Res Acq LLC North Miami

Miami, Florida, United States, 33138

Actively Recruiting

12

Inpatient Research Clinical LLC

Miami Lakes, Florida, United States, 33014

Actively Recruiting

13

Advanced Research for Health Improvement LLC

Naples, Florida, United States, 34102

Active, Not Recruiting

14

Midwest Heart and Vascular Spec

Overland Park, Kansas, United States, 66211

Actively Recruiting

15

Tufts Medical Center

Boston, Massachusetts, United States, 02111

Actively Recruiting

16

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

17

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

18

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts, United States, 02115

Actively Recruiting

19

Brigham and Womens Hosp Harvard Med School

Boston, Massachusetts, United States, 02115

Actively Recruiting

20

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

21

Henry Ford Hospital

Detroit, Michigan, United States, 48202

Actively Recruiting

22

AA Medical Research Center

Flint, Michigan, United States, 48504

Actively Recruiting

23

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073-4192

Actively Recruiting

24

Minneapolis Heart Institute

Minneapolis, Minnesota, United States, 55407

Withdrawn

25

University Of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

26

Overlook Medical Center

Summit, New Jersey, United States, 07901

Actively Recruiting

27

Capital Cardiology Associates

Albany, New York, United States, 12211

Actively Recruiting

28

New York Presbyterian Hospital

New York, New York, United States, 10021

Active, Not Recruiting

29

Icahn School of Med at Mt Sinai

New York, New York, United States, 10029

Actively Recruiting

30

Strong Memorial Hospital

Rochester, New York, United States, 14642

Actively Recruiting

31

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

32

Lindner Ctr At The Christ Hosp

Cincinnati, Ohio, United States, 45219

Actively Recruiting

33

Ohio State University

Columbus, Ohio, United States, 43210

Withdrawn

34

Perelman School of Medicine

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

35

Orion Medical

Houston, Texas, United States, 77034

Actively Recruiting

36

Virginia Heart

Falls Church, Virginia, United States, 22042

Actively Recruiting

37

Carient Heart and Vascular

Manassas, Virginia, United States, 20109

Actively Recruiting

38

Novartis Investigative Site

Innsbruck, Tyrol, Austria, 6020

Actively Recruiting

39

Novartis Investigative Site

Linz, Austria, 4021

Withdrawn

40

Novartis Investigative Site

Vienna, Austria, 1100

Actively Recruiting

41

Novartis Investigative Site

Vienna, Austria, 1190

Actively Recruiting

42

Novartis Investigative Site

Vienna, Austria, A 1090

Actively Recruiting

43

Novartis Investigative Site

Genk, Limburg, Belgium, 3600

Actively Recruiting

44

Novartis Investigative Site

Yvoir, Namur, Belgium, 5530

Actively Recruiting

45

Novartis Investigative Site

Aalst, Oost Vlaanderen, Belgium, 9300

Actively Recruiting

46

Novartis Investigative Site

Kortrijk, West-Vlaanderen, Belgium, 8500

Actively Recruiting

47

Novartis Investigative Site

Roeselare, West-Vlaanderen, Belgium, 8800

Actively Recruiting

48

Novartis Investigative Site

Cambridge, Ontario, Canada, N1R 6V6

Actively Recruiting

49

Novartis Investigative Site

North York, Ontario, Canada, M6B 3H7

Actively Recruiting

50

Novartis Investigative Site

Ottawa, Ontario, Canada, K1Y 4W7

Actively Recruiting

51

Novartis Investigative Site

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

52

Novartis Investigative Site

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

53

Novartis Investigative Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

54

Novartis Investigative Site

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

55

Novartis Investigative Site

Hradec Králové, Czechia, 500 02

Actively Recruiting

56

Novartis Investigative Site

Jaroměř, Czechia, 551 01

Actively Recruiting

57

Novartis Investigative Site

Prague, Czechia, 128 08

Actively Recruiting

58

Novartis Investigative Site

Prague, Czechia, 14021

Actively Recruiting

59

Novartis Investigative Site

Prague, Czechia, 150 06

Actively Recruiting

60

Novartis Investigative Site

Esbjerg, Denmark, 6700

Actively Recruiting

61

Novartis Investigative Site

Hvidovre, Denmark, 2650

Actively Recruiting

62

Novartis Investigative Site

Roskilde, Denmark, 4000

Actively Recruiting

63

Novartis Investigative Site

Viborg, Denmark, 8800

Actively Recruiting

64

Novartis Investigative Site

Paris, France, 75012

Actively Recruiting

65

Novartis Investigative Site

Paris, France, 75013

Actively Recruiting

66

Novartis Investigative Site

Paris, France, 75015

Actively Recruiting

67

Novartis Investigative Site

Pessac, France, 33604

Actively Recruiting

68

Novartis Investigative Site

Poitiers, France, 86021

Actively Recruiting

69

Novartis Investigative Site

Rennes, France, 35033

Actively Recruiting

70

Novartis Investigative Site

Frankfurt am Main, Hesse, Germany, 60594

Actively Recruiting

71

Novartis Investigative Site

Kaiserslautern, Rhineland-Palatinate, Germany, 67655

Actively Recruiting

72

Novartis Investigative Site

Dresden, Saxony, Germany, 01099

Actively Recruiting

73

Novartis Investigative Site

Leipzig, Saxony, Germany, 04289

Actively Recruiting

74

Novartis Investigative Site

Ahaus, Germany, 48683

Actively Recruiting

75

Novartis Investigative Site

Berlin, Germany, 13353

Actively Recruiting

76

Novartis Investigative Site

Bonn, Germany, 53105

Actively Recruiting

77

Novartis Investigative Site

Essen, Germany, 45147

Actively Recruiting

78

Novartis Investigative Site

Hamburg, Germany, 20246

Actively Recruiting

79

Novartis Investigative Site

Hamburg, Germany, 22763

Actively Recruiting

80

Novartis Investigative Site

Lüneburg, Germany, 21339

Withdrawn

81

Novartis Investigative Site

Mannheim, Germany, 68165

Actively Recruiting

82

Novartis Investigative Site

München, Germany, 80636

Actively Recruiting

83

Novartis Investigative Site

Münster, Germany, 48149

Actively Recruiting

84

Novartis Investigative Site

Oldenburg, Germany, 26133

Actively Recruiting

85

Novartis Investigative Site

Beersheba, Israel, 8457108

Actively Recruiting

86

Novartis Investigative Site

Haifa, Israel, 3104802

Actively Recruiting

87

Novartis Investigative Site

Haifa, Israel, 3109601

Actively Recruiting

88

Novartis Investigative Site

Jerusalem, Israel, 9103102

Actively Recruiting

89

Novartis Investigative Site

Jerusalem, Israel, 9112001

Actively Recruiting

90

Novartis Investigative Site

Nahariya, Israel, 2210001

Actively Recruiting

91

Novartis Investigative Site

Petah Tikva, Israel, 4941492

Actively Recruiting

92

Novartis Investigative Site

Ramat Gan, Israel, 5265601

Actively Recruiting

93

Novartis Investigative Site

Tel Aviv, Israel, 6423906

Actively Recruiting

94

Novartis Investigative Site

Ancona, AN, Italy, 60126

Actively Recruiting

95

Novartis Investigative Site

Bergamo, BG, Italy, 24127

Actively Recruiting

96

Novartis Investigative Site

Bologna, BO, Italy, 40138

Withdrawn

97

Novartis Investigative Site

Brescia, BS, Italy, 25123

Actively Recruiting

98

Novartis Investigative Site

Caserta, CE, Italy, 81100

Actively Recruiting

99

Novartis Investigative Site

Cona, FE, Italy, 44124

Actively Recruiting

100

Novartis Investigative Site

Pozzilli, IS, Italy, 86077

Actively Recruiting

101

Novartis Investigative Site

Milan, MI, Italy, 20138

Actively Recruiting

102

Novartis Investigative Site

Milan, MI, Italy, 20157

Actively Recruiting

103

Novartis Investigative Site

Milan, MI, Italy, 20162

Actively Recruiting

104

Novartis Investigative Site

Padova, PD, Italy, 35128

Actively Recruiting

105

Novartis Investigative Site

Pordenone, PN, Italy, 33170

Actively Recruiting

106

Novartis Investigative Site

Amsterdam, North Holland, Netherlands, 1090 HM

Actively Recruiting

107

Novartis Investigative Site

Amsterdam, North Holland, Netherlands, 1105 AZ

Actively Recruiting

108

Novartis Investigative Site

Rotterdam, South Holland, Netherlands, 3015 GD

Actively Recruiting

109

Novartis Investigative Site

Rotterdam, South Holland, Netherlands, 3079 DZ

Actively Recruiting

110

Novartis Investigative Site

Nieuwegein, Utrecht, Netherlands, 3435 CM

Actively Recruiting

111

Novartis Investigative Site

Alcabideche, Portugal, 2755-009

Actively Recruiting

112

Novartis Investigative Site

Braga, Portugal, 4710243

Actively Recruiting

113

Novartis Investigative Site

Coimbra, Portugal, 3004-561

Actively Recruiting

114

Novartis Investigative Site

Vila Nova de Gaia, Portugal, 4434 502

Actively Recruiting

115

Novartis Investigative Site

Cáceres, Extremadura, Spain, 10003

Actively Recruiting

116

Novartis Investigative Site

Córdoba, Spain, 14004

Actively Recruiting

117

Novartis Investigative Site

Madrid, Spain, 28034

Actively Recruiting

118

Novartis Investigative Site

Madrid, Spain, 28040

Withdrawn

119

Novartis Investigative Site

Madrid, Spain, 28041

Actively Recruiting

120

Novartis Investigative Site

Madrid, Spain, 28046

Actively Recruiting

121

Novartis Investigative Site

Salamanca, Spain, 37007

Actively Recruiting

122

Novartis Investigative Site

Valencia, Spain, 46010

Actively Recruiting

123

Novartis Investigative Site

Basel, Switzerland, 4031

Actively Recruiting

124

Novartis Investigative Site

Geneva, Switzerland, 1211

Actively Recruiting

125

Novartis Investigative Site

Lausanne, Switzerland, 1011

Actively Recruiting

126

Novartis Investigative Site

Lugano, Switzerland, 6900

Actively Recruiting

127

Novartis Investigative Site

Zurich, Switzerland, 8091

Actively Recruiting

128

Novartis Investigative Site

Reading, Berkshire, United Kingdom, RG1 5AN

Actively Recruiting

129

Novartis Investigative Site

Portadown, Nothern Ireland, United Kingdom, BT63 5QQ

Actively Recruiting

130

Novartis Investigative Site

Edinburgh, United Kingdom, ED16 4SA

Actively Recruiting

131

Novartis Investigative Site

Leicester, United Kingdom, LE3 9QP

Actively Recruiting

132

Novartis Investigative Site

Liverpool, United Kingdom, L14 3PE

Actively Recruiting

133

Novartis Investigative Site

London, United Kingdom, EC1A 7BE

Actively Recruiting

134

Novartis Investigative Site

London, United Kingdom, SE1 7EH

Actively Recruiting

135

Novartis Investigative Site

Londonderry, United Kingdom, BT47 6SB

Actively Recruiting

136

Novartis Investigative Site

Manchester, United Kingdom, M23 9LT

Actively Recruiting

137

Novartis Investigative Site

Middlesbrough, United Kingdom, TS4 3BW

Actively Recruiting

138

Novartis Investigative Site

Norwich, United Kingdom, NR4 7UY

Actively Recruiting

139

Novartis Investigative Site

Tyne and Wear, United Kingdom, NE29 8NH

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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