Ignite Creation Date:
2024-05-06 @ 7:24 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02525939
Status:
COMPLETED
Last Update Posted:
2022-10-12
First Post:
2015-08-13
Brief Title:
Effect of Dalcetrapib vs Placebo on CV Risk in a Genetically Defined Population With a Recent ACS
Sponsor:
DalCor Pharmaceuticals
Organization:
DalCor Pharmaceuticals
Study Overview
Official Title:
A Phase III Double-blind Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular CV Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome ACS The Dal-GenE Trial
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
dal-GenE
Brief Summary:
A placebo-controlled randomized double-blind parallel group phase III multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile Subjects will provide informed consent before any study-specific procedures are performed Subject enrollment may begin in the hospital and will continue following release from the hospital Screening procedures may be performed at the time of the index ACS event or anytime thereafter with the condition that randomization must occur within the mandated window 4-12 weeks after the index event Subjects will be assessed based on their medical history Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype
Detailed Description:
This is an event driven study to reach statistical power given all other assumptions Subjects will visit the clinic 1 month after randomization and at regular intervals thereafter Additionally for any subject prematurely discontinuing study medication assessments will be conducted every 6 months for the collection of study endpoints
Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389
Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype The test is investigational and test procedures are Roche Molecular Diagnostics protocol ADCY9-COB-389
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None