Dalcetrapib for Heart Attack

(dal-GenE-2 Trial)

Recruiting at 37 trial locations

Overseen By Therese Heinonen, DVM

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. ^{1 2 3 4 5}

Research Team

David Kallend, MBBS

Principal Investigator

DalCor

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

Treatment Details

Interventions

• Dalcetrapib (CETP Inhibitor)
• Placebo (Drug)

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

DalCor Pharmaceuticals

Lead Sponsor

Trials

3

Recruited

8,400+

The Montreal Health Innovations Coordinating Center (MHICC)

Collaborator

Trials

14

Recruited

10,900+

Findings from Research

In a study of 16,237 patients with their first myocardial infarction, 4.4% were identified as having myocardial infarction with non-obstructive coronary artery disease (MINOCA), and 55% of these patients were discharged on dual antiplatelet therapy (DAPT).

Factors such as being male, being an active smoker, having a history of previous percutaneous intervention, experiencing ST elevation myocardial infarction, and being in sinus rhythm at admission were identified as independent predictors for the use of DAPT in MINOCA patients, suggesting these groups may be at higher risk for thrombotic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual antiplatelet therapy in myocardial infarction with non-obstructive coronary artery disease - insights from a nationwide registry. Montenegro Sá, F., Carvalho, R., Santos, L., et al.[2021]

A network meta-analysis of 15 randomized controlled trials involving 55,798 patients with acute coronary syndrome (ACS) found that de-escalating dual antiplatelet therapy (DAPT) to clopidogrel or low-dose prasugrel significantly reduced the risk of bleeding events without compromising cardiovascular safety outcomes.

De-escalation therapy was associated with a lower risk of major and minor bleeding compared to standard doses of other P2Y12 inhibitors, while maintaining similar efficacy in preventing cardiovascular death, myocardial infarction, and stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-Escalation of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndromes. Shoji, S., Kuno, T., Fujisaki, T., et al.[2022]

In a study of 3,691 patients with stable coronary artery disease, 24% were treated with dual-antiplatelet therapy (DAPT), with factors like persistent angina and prior myocardial infarction influencing its use.

The study found no significant difference in the rates of cardiovascular events between patients on DAPT (5.5%) and those on single-antiplatelet therapy (SAPT) (4.6%) over two years, suggesting that prolonged DAPT does not provide additional benefits in this patient population.

NCBI (Pubmed)

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). Lemesle, G., Lamblin, N., Meurice, T., et al.[2014]

In a study of 100 patients undergoing transcatheter aortic valve implantation (TAVI), clopidogrel platelet reactivity testing before and after the procedure was found to be a significant predictor of in-hospital bleeding, with specific cut-off values indicating increased risk.

The results suggest that monitoring clopidogrel response is crucial, as a significant drop in platelet reactivity during the procedure correlates with higher bleeding risk, while aspirin response did not show the same predictive value.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of platelet reactivity assessment in dual antiplatelet prophylaxis after transcatheter aortic valve implantation. Czerwińska-Jelonkiewicz, K., Witkowski, A., Dąbrowski, M., et al.[2018]

In a study of 120 patients undergoing transcatheter aortic valve implantation (TAVI), single antiplatelet therapy (aspirin only) was found to be as safe as dual antiplatelet therapy (DAPT) without increasing morbidity or mortality over a 6-month follow-up period.

Patients receiving single antiplatelet therapy experienced fewer vascular complications at 30 days compared to those on DAPT, suggesting that DAPT may not be necessary for TAVI procedures.

NCBI (Pubmed)

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. Stabile, E., Pucciarelli, A., Cota, L., et al.[2022]

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]

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

De-Escalation of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndromes. [2022]

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]

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

The role of platelet reactivity assessment in dual antiplatelet prophylaxis after transcatheter aortic valve implantation. [2018]

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]