A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis
Part of paid clinical trials in Huntsville, Alabama.
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT05646381
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Aortic Stenosis
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Pelacarsen (TQJ230) 80mg — DRUGPelacarsen (TQJ230) 80mg
- Matching placebo — DRUGMatching placebo
Study Details
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.
Key Dates
- Start date
- Mar 7, 2024
- Status verified
- May 2026
- Primary completion
- Mar 12, 2030
- Completion
- Mar 12, 2030
Study Design
- Enrollment
- 502 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Pelacarsen (TQJ230) 80mgPelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
- Placebo Comparator: Matching placeboPlacebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Primary Outcome Measure
Change in peak aortic jet velocity [ Time Frame: 36 months ]
Central Contacts
- Novartis Pharmaceuticals1-888-669-6682
- Novartis Pharmaceuticals+41613241111
Locations (37)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Heart Center Research Llc | Huntsville | Alabama | 35801 | Vernon R Hunter (PRINCIPAL_INVESTIGATOR) |
| Cardiovascular Res Found | Beverly Hills | California | 90210 | Ronald P Karlsberg (PRINCIPAL_INVESTIGATOR) |
| National Heart Institute | Beverly Hills | California | 90211 | Norman Lepor (PRINCIPAL_INVESTIGATOR) |
| Flourish Clinical Resrch Covin | Covina | California | 91723 | Fahed Bitar (PRINCIPAL_INVESTIGATOR) |
| Valley Clinical Trials | Northridge | California | 91325 | Mehrdad Ariani (PRINCIPAL_INVESTIGATOR) |
| Stanford University Medical Center | Palo Alto | California | 94304 | Abha Khandelwal (PRINCIPAL_INVESTIGATOR) |
| University Of California San Diego | San Diego | California | 92103-8415 | Anna Narezkina (PRINCIPAL_INVESTIGATOR) |
| UC San Francisco Medical Center | San Francisco | California | 94143 | Eveline Stock (PRINCIPAL_INVESTIGATOR) |
| Excel Medical Clinical Trials LLC | Boca Raton | Florida | 33434 | - |
| Nova Clinical Research LLC | Bradenton | Florida | 34209 | Christian Zellner (PRINCIPAL_INVESTIGATOR) |
| Flourish Res Acq LLC North Miami | Miami | Florida | 33138 | Ashlee Sealy Rimsky Denis. (PRINCIPAL_INVESTIGATOR) |
| Inpatient Research Clinical LLC | Miami Lakes | Florida | 33014 | Alexis Gutierrez. (PRINCIPAL_INVESTIGATOR) |
| Advanced Research for Health Improvement LLC | Naples | Florida | 34102 | - |
| Midwest Heart and Vascular Spec | Overland Park | Kansas | 66211 | Vasvi Singh. (PRINCIPAL_INVESTIGATOR) |
| Brigham and Womens Hosp Harvard Med School | Boston | Massachusetts | 02115 | Rhanderson Cardoso (PRINCIPAL_INVESTIGATOR) |
| Brigham and Womens Hosp Harvard Med School | Boston | Massachusetts | 02115 | Rhanderson Cardoso (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Michael Honigberg (PRINCIPAL_INVESTIGATOR) |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | Victoria Viscosi Michael Honigberg (PRINCIPAL_INVESTIGATOR) |
| Tufts Medical Center | Boston | Massachusetts | 02111 | Benjamin Wessler (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Jodi Carter, BS, CCRP +1 (313) 916-3613 Khaled Abdul-Nour (PRINCIPAL_INVESTIGATOR) |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Khaled Abdul-Nour (PRINCIPAL_INVESTIGATOR) |
| AA Medical Research Center | Flint | Michigan | 48504 | Ahmed A Arif. (PRINCIPAL_INVESTIGATOR) |
| William Beaumont Hospital | Royal Oak | Michigan | 48073-4192 | Joel Skaistis (PRINCIPAL_INVESTIGATOR) |
| Minneapolis Heart Institute | Minneapolis | Minnesota | 55407 | - |
| University Of Minnesota | Minneapolis | Minnesota | 55455 | Daniel Duprez (PRINCIPAL_INVESTIGATOR) |
| Overlook Medical Center | Summit | New Jersey | 07901 | Robert Fishberg. (PRINCIPAL_INVESTIGATOR) |
| Capital Cardiology Associates | Albany | New York | 12211 | Shreya Shah Lance Sullenberger. (PRINCIPAL_INVESTIGATOR) |
| Icahn School of Med at Mt Sinai | New York | New York | 10029 | Robert Rosenson. (PRINCIPAL_INVESTIGATOR) |
| New York Presbyterian Hospital | New York | New York | 10021 | - |
| Strong Memorial Hospital | Rochester | New York | 14642 | Robert Block (PRINCIPAL_INVESTIGATOR) |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Donna Davis Michael Shapiro (PRINCIPAL_INVESTIGATOR) |
| Lindner Ctr At The Christ Hosp | Cincinnati | Ohio | 45219 | Sitaramesh Emani (PRINCIPAL_INVESTIGATOR) |
| Ohio State University | Columbus | Ohio | 43210 | - |
| Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | Manali Shah Archna Bajaj (PRINCIPAL_INVESTIGATOR) |
| Orion Medical | Houston | Texas | 77034 | Lena Olivera Perez Karan Bhalla (PRINCIPAL_INVESTIGATOR) |
| Virginia Heart | Falls Church | Virginia | 22042 | Tariq Haddad (PRINCIPAL_INVESTIGATOR) |
| Carient Heart and Vascular | Manassas | Virginia | 20109 | Vikram Prasanna (PRINCIPAL_INVESTIGATOR) |
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