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CETP Inhibitor

Dalcetrapib for Heart Attack (dal-GenE-2 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
AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)
Both male and female subjects age 45 years and over at screening visit (V1)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up average of 30 months from randomization
Awards & highlights

dal-GenE-2 Trial Summary

This trial tests a drug to treat a genetic form of heart attack. Subjects with the right genetic profile will give consent, and will be tested and assessed for eligibility. Randomization must occur within 12 weeks of the heart attack.

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.Check my eligibility
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.See study design
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.

dal-GenE-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My genetic test shows I have the AA genotype.
Select...
I am 45 years old or older.
Select...
I haven't had chest pain or discomfort when resting or with light activity for at least a week.

dal-GenE-2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)
Secondary outcome measures
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
1%
Neuropathy Peripheral
1%
Malaise
1%
Constipation
1%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dalcetrapib 600mg
Dalcetrapib 300mg
Dalcetrapib 900mg
Placebo

dal-GenE-2 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

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.

Find a Location

Who is running the clinical trial?

The Montreal Health Innovations Coordinating Center (MHICC)OTHER
13 Previous Clinical Trials
8,886 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
6,147 Patients Enrolled for Acute Coronary Syndrome
DalCor PharmaceuticalsLead Sponsor
2 Previous Clinical Trials
6,374 Total Patients Enrolled
1 Trials studying Acute Coronary Syndrome
6,147 Patients Enrolled for Acute Coronary Syndrome
David Kallend, MBBSStudy DirectorDalCor

Media Library

Dalcetrapib (CETP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05918861 — Phase 3
Acute Coronary Syndrome Research Study Groups: Placebo, Dalcetrapib
Acute Coronary Syndrome Clinical Trial 2023: Dalcetrapib Highlights & Side Effects. Trial Name: NCT05918861 — Phase 3
Dalcetrapib (CETP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05918861 — Phase 3
~1333 spots leftby Aug 2027
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