What side effects are associated with this type of intervention?

Common treatments for Acute Coronary Syndrome (ACS) include antiplatelet agents (e.g., aspirin, clopidogrel), anticoagulants (e.g., heparin, enoxaparin), beta-blockers, ACE inhibitors, and statins. Known side effects of these treatments can include bleeding (antiplatelet agents and anticoagulants), bradycardia and hypotension (beta-blockers), cough and hyperkalemia (ACE inhibitors), and muscle pain or liver enzyme abnormalities (statins). For genotype-specific drugs like the one being studied for the AA genotype in ACS patients, side effects would depend on the specific mechanism of action but could include genetic-specific adverse reactions and common drug-related side effects such as gastrointestinal issues or allergic reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Acute Coronary Syndrome (ACS), focusing on both broad and targeted therapies. Commonly approved drugs include antiplatelet agents like clopidogrel, prasugrel, and ticagrelor, which help prevent blood clots. Statins such as atorvastatin and rosuvastatin are also widely used to lower cholesterol levels and reduce cardiovascular risk. In the context of genotype-specific treatments, the trial studying a targeted therapy for ACS in the AA genotype represents a more personalized approach, although specific FDA-approved drugs for this genotype are not detailed. Overall, the treatment landscape for ACS includes a combination of antiplatelet agents, statins, and other supportive medications to manage and reduce the risk of further cardiovascular events.

What other types of research exist?

Promising novel alternatives for treating Acute Coronary Syndrome (ACS) patients in 2024 include PCSK9 inhibitors (e.g., evolocumab, alirocumab), which have shown efficacy in lowering LDL cholesterol and reducing cardiovascular events. Additionally, RNA-based therapies like inclisiran, which targets PCSK9, offer a novel mechanism for cholesterol management. Anti-inflammatory therapies, such as canakinumab, which targets interleukin-1β, have also demonstrated potential in reducing cardiovascular risk. These alternatives provide new avenues for managing ACS beyond genotype-specific drug therapies.

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CETP Inhibitor

Dalcetrapib for Heart Attack (dal-GenE-2 Trial)

Verified Trial

Phase 3

Recruiting

Research Sponsored by DalCor Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Are you 45 years or older?

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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average of 30 months from randomization

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the side effects of Dalcetrapib aren't detailed here, similar medications often cause issues like nausea, muscle pain, increased liver enzymes or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average of 30 months from randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average of 30 months from randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and average of 30 months from randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)

Secondary study objectives

Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke

Fatal and non-fatal MI

The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke

Side effects data

From 2006 Phase 2 trial • 292 Patients • NCT00697203

Neuropathy Peripheral

Malaise

Constipation

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Dalcetrapib 600mg

Dalcetrapib 300mg

Dalcetrapib 900mg

Placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DalcetrapibExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dalcetrapib

2005

Completed Phase 2

~520

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Acute Coronary Syndrome (ACS) include antiplatelet agents, statins, beta-blockers, and ACE inhibitors. Antiplatelet agents, such as aspirin and clopidogrel, prevent platelet aggregation, reducing the risk of clot formation. Statins lower LDL cholesterol levels, stabilizing atherosclerotic plaques and reducing inflammation. Beta-blockers decrease heart rate and myocardial oxygen demand, helping to prevent further ischemic events. ACE inhibitors reduce blood pressure and afterload, improving cardiac function. In the context of genotype-specific treatments like Dalcetrapib, which targets patients with the AA genotype, the focus is on modulating HDL cholesterol levels to reduce cardiovascular risk. These treatments are crucial for ACS patients as they address different aspects of the disease process, from preventing clot formation to stabilizing plaques and improving heart function, thereby reducing the risk of recurrent events and improving outcomes.