Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353067
Status:
SUSPENDED
Last Update Posted:
2006-11-29
First Post:
2006-07-14
Brief Title:
Veliflapon DG-031to Prevent Heart Attacks or Stroke in Patients With a History of Heart Attack or Unstable Angina
Sponsor:
deCODE genetics
Organization:
deCODE genetics
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study to Examine the Safety and Efficacy of Veliflapon DG-031 in Reducing the Risk of Acute Cardiovascular Events in African American Patients With Coronary Artery DiseaseThe LTCAD Study
Status:
SUSPENDED
Status Verified Date:
2006-11
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:
None
Brief Summary:
The purpose of this study is to determine if veliflapon DG-031can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction
Detailed Description:
Genetic linkage and association studies in Icelandic patients with a history of myocardial infarction and stroke showed common haplotypes in two genes 5-lipoxygenase activating proteinFLAPand Leukotriene A4 HydrolaseLTA4H that each conferred significant risk for MI and stroke The FLAP haplotype had a RR of 18 for MI and 21 for those with MI and stroke LTA4H haplotype had a RR of 11 for MI and 15 for MI and strokeBoth gene associations were replicated in European and US Caucasian groups and were independent of the conventional risk factors such as LDL-cholesterol hypertension and diabetes The haplotype for the LTA4H pathway showed a modest relative risk of 12 in US Caucasian cohorts for all MI and 14 for MI and stroke However the LTA4H haplotype had a much higher relative risk of 35 for myocardial infarction in African-Americans p0000022
Self identified African American patients with acute coronary syndrome ACS were selected for this study as this population has the highest risk identified to date for developing an MI related to the HapK genetic variant in the leukotriene pathway The study will be enriched to include African American patients randomized by an algorithm designed to assure that approximately 80 of the study population will be Hap K positive and 20 will not have the Hap K positive result
All patients will be screened for eligibility based on the haplotype status Patients will be randomized to either veliflapon or placebo on top of standard care Patients are randomized within 5-30 days of their ACS event
This is an events driven study with the time of the first occurrence of any of the following elements hospitalization for UA or urgent revascularization fatalnon-fatal MI fatalnon-fatal stroke and CV related death comprising the primary endpoint The primary null hypothesis of efficacy is that time to first CV event among African American patients with a positive LTA4H HapK Variant assay test is no different from placebo when either is given in addition to standard of care therapy A total of 3450 eligible patients will be randomized in this study
The treatment duration for patients enrolled in the study will be a target of at least 6 months based on approximate time of last patient enrolled and up to 36 months from first patient enrolled All cardiac clinical events endpoints will be adjudicated by an independent Clinical Endpoint Committee CEC
Self identified African American patients with acute coronary syndrome ACS were selected for this study as this population has the highest risk identified to date for developing an MI related to the HapK genetic variant in the leukotriene pathway The study will be enriched to include African American patients randomized by an algorithm designed to assure that approximately 80 of the study population will be Hap K positive and 20 will not have the Hap K positive result
All patients will be screened for eligibility based on the haplotype status Patients will be randomized to either veliflapon or placebo on top of standard care Patients are randomized within 5-30 days of their ACS event
This is an events driven study with the time of the first occurrence of any of the following elements hospitalization for UA or urgent revascularization fatalnon-fatal MI fatalnon-fatal stroke and CV related death comprising the primary endpoint The primary null hypothesis of efficacy is that time to first CV event among African American patients with a positive LTA4H HapK Variant assay test is no different from placebo when either is given in addition to standard of care therapy A total of 3450 eligible patients will be randomized in this study
The treatment duration for patients enrolled in the study will be a target of at least 6 months based on approximate time of last patient enrolled and up to 36 months from first patient enrolled All cardiac clinical events endpoints will be adjudicated by an independent Clinical Endpoint Committee CEC
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