Dalcetrapib for Heart Attack

(dal-GenE-2 Trial)

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: DalCor Pharmaceuticals

Must be taking: Lipid-lowering drugs

Disqualifiers: Pregnancy, Heart failure, Hypertension, Liver disease, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment for people who have been hospitalized for a heart problem. The treatment is given to those with a certain genetic makeup. The goal is to see if this special medicine works better for them because of their genes.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does require that you have evidence of guidelines-based management of LDL-C, which includes medical and dietary treatment. It's best to discuss your current medications with the trial team.

How is the drug Dalcetrapib unique for treating heart attacks?

Dalcetrapib is unique because it targets cholesterol levels by inhibiting a protein called CETP (cholesteryl ester transfer protein), which is different from the common dual antiplatelet therapy (DAPT) used for heart attack treatment. This approach may offer a novel way to manage heart attack risk by focusing on cholesterol rather than blood clot prevention.

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Eligibility Criteria

This trial is for adults over 45 who've been hospitalized with Acute Coronary Syndrome (ACS) within the last 3 months, are stable, and have a specific AA genotype. They must be on LDL-C management and not pregnant or breastfeeding. Excluded are those with severe kidney/liver disease, uncontrolled hypertension, certain heart failures, recent other trials participation or life expectancy under 3 years.

Inclusion Criteria

Are you 45 years or older?

Have you had a Heart Attack in the past 2-3 months?

Have you been diagnosed with Myocardial Infarction in the past 2-3 months?

Exclusion Criteria

Have you undergone coronary artery bypass graft (CABG) surgery in the past 2-3 months?

Trial Timeline

Pre-screening

Initial pre-screening genetic testing for AA genotype

Not specified

Screening

Participants are screened for eligibility to participate in the trial

Up to 12 weeks

Treatment

Participants receive either Dalcetrapib or placebo and are monitored for cardiovascular events

Average of 30 months

Every 3 months (virtual or clinic visits)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Not specified

Participant Groups

The study tests Dalcetrapib's effect on cardiovascular risk in patients with a recent ACS event and a particular genetic profile. It's randomized (patients assigned by chance), double-blind (neither researchers nor participants know who gets what treatment), comparing Dalcetrapib against a placebo.

Group I: Dalcetrapib Experimental Treatment 1 Intervention

Dalcetrapib 600 mg (two 300 mg tablets) orally once daily

Group II: Placebo Placebo Group 1 Intervention

Matching dalcetrapib placebo tablets (2 tablets) orally once per day

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site La Jolla, CA

Research Site San Francisco, CA

Research Site Stanford, CA

Research Site Gainesville, FL

More Trial Locations

Who Is Running the Clinical Trial?

DalCor Pharmaceuticals Lead Sponsor

The Montreal Health Innovations Coordinating Center (MHICC) Collaborator

References

1. Spain pubmed.ncbi.nlm.nih.gov

Dual antiplatelet therapy in myocardial infarction with non-obstructive coronary artery disease - insights from a nationwide registry. [2021] Dual antiplatelet therapy (DAPT) is a mainstay for myocardial infarction (MI) therapy. However, in patients with myocardial infarction with non-obstructive coronary artery disease (MINOCA), clear recommendations are lacking in the literature. This study aims to identify the cases in which DAPT is currently prescribed at discharge for MINOCA.

2. United States pubmed.ncbi.nlm.nih.gov

De-Escalation of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndromes. [2022] Label="BACKGROUND">Balancing the effects of dual antiplatelet therapy (DAPT) in the era of potent P2Y12 inhibitors has become a cornerstone of acute coronary syndrome (ACS) management. Recent randomized controlled trials (RCTs) have investigated DAPT de-escalation to decrease the risk of bleeding outcomes.

3. United States pubmed.ncbi.nlm.nih.gov

Dual antiplatelet therapy in patients with stable coronary artery disease in modern practice: prevalence, correlates, and impact on prognosis (from the Suivi d'une cohorte de patients COROnariens stables en region NORd-Pas-de-Calais study). [2014] The prevalence and correlates of dual-antiplatelet therapy (DAPT) use in stable coronary artery disease (CAD) are unknown. In addition, whether prolonged DAPT may impact prognosis in stable CAD has not been studied in real-life conditions.

4. Netherlands pubmed.ncbi.nlm.nih.gov

The role of platelet reactivity assessment in dual antiplatelet prophylaxis after transcatheter aortic valve implantation. [2018] Dual antiplatelet therapy (DAPT) is recommended prophylaxis after transcatheter aortic valve implantation (TAVI). The usefulness of platelet reactivity (PLTR) tests in predicting the safety of periprocedural DAPT in the TAVI population is unknown.

5. Netherlands pubmed.ncbi.nlm.nih.gov

SAT-TAVI (single antiplatelet therapy for TAVI) study: a pilot randomized study comparing double to single antiplatelet therapy for transcatheter aortic valve implantation. [2022] Common clinical practice recommends dual antiplatelet therapy (DAPT) for transcatheter aortic valve implantation (TAVI). The aim of the study was to evaluate, in a double blind randomized study, the safety of TAVI, with adjunctive pharmacotherapy consisting of single antiplatelet therapy.