NCT00353067

Brief Summary

The purpose of this study is to determine if veliflapon (DG-031)can prevent a heart attack or stroke in African American patients with a history of unstable angina or myocardial infarction.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
3,450

participants targeted

Target at P75+ for phase_3

Geographic Reach
1 country

11 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2006

Completed
Last Updated

November 29, 2006

Status Verified

November 1, 2006

First QC Date

July 14, 2006

Last Update Submit

November 28, 2006

Conditions

Acute Coronary Syndrome

Keywords

unstable anginamyocardial infarctioncoronary thrombosiscoronary atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Time to first occurrence of a composite endpoint including:hospitalization for unstable angina or urgent revascularization; fatal/non-fatal MI; fatal/non-fatal stroke or CV related death

Secondary Outcomes (2)

  • Time to first occurrence of each of the following: an acute CV event (one of the composite CV events) among ALL randomized patients; MI, fatal and non-fatal

  • Stroke, fatal and non-fatal; CV related death and all cause mortality.

Interventions

veliflapon (DG-031)DRUG

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • years of age or older
  • African American by self-report.
  • A history of either acute MI or admission for unstable angina (UA)within 30 days of randomization
  • Women who have undergone surgical sterilization (hysterectomy or bilateral tubal ligation or bilateral oophorectomy)or are \> 2 years post-menopausal by medical history are also eligible.
  • Women of childbearing potential must have a negative urine pregnancy test and are required to use 2 barrier methods of contraception throughout the study.
  • Patients are capable of understanding study procedures and agree to participate in the study including scheduled follow up visits and consent to genetic haplotype testing.

You may not qualify if:

  • Presence of active, symptomatic HF defined by presence of New York Heart Association Class II-IV at time of screening.
  • Received any treatment with an investigational agent or device within 4 weeks.
  • Evidence of secondary angina or ischemia
  • Underlying cardiac disorders that may cause cardiac ischemia including aortic stenosis or hypertrophic cardiomyopathy.
  • Presence of active hepatic disease or AST and/or ALT \> 3.0 Ă— ULN.
  • Calculated creatinine clearance \< 30 ml/minute OR the presence of chronic and severe renal insufficiency.
  • Major surgery performed within six weeks prior to scheduled day of randomization.
  • Any other major intercurrent illness and other condition, which, in the opinion of the Investigator, will interfere with the patient's participation in the study or leads to a survival prognosis of \< 5 years.
  • A history of additional risk factors for Torsades de Pointe (TdP)
  • Patients who are not willing to return for follow up visits or with a known history of non-compliance.
  • Patients who consume \> 3 alcoholic drinks/day or \> 15 drinks/week, or have a history of alcohol abuse within the past 2 years.
  • History of active drug abuse within 1 year of screening for the study.
  • Pregnant or lactating women.
  • Poor mental function or any other reason that may cause difficulty in complying with the requirements of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Montgomery, Alabama, 36106, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Melrose Park, Illinois, 60160, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, 73103, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19142, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Carrollton, Texas, 75007, United States

Location

Unknown Facility

Fort Worth, Texas, 76104, United States

Location

Unknown Facility

Richardson, Texas, 75080, United States

Location

Unknown Facility

Hopewell, Virginia, 23860, United States

Location

Unknown Facility

Suffolk, Virginia, 23434, United States

Location

MeSH Terms

Conditions

Acute Coronary SyndromeAngina, UnstableMyocardial InfarctionCoronary ThrombosisCoronary Artery Disease

Interventions

2-(4-(quinolin-2-yl-methoxy)phenyl)-2-cyclopentylacetic acid

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosisCoronary DiseaseThrombosisEmbolism and ThrombosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Douglas W Weaver, M.D.

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

  • Christopher Granger, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 14, 2006

First Posted

July 17, 2006

Study Start

May 1, 2006

Last Updated

November 29, 2006

Record last verified: 2006-11

Locations

US(11)