NL-OMON55786
Completed
Phase 3
A phase III, double-blind, randomized placebo-controlled study to evaluate the effects of dacetrapib on cardiovascular (CV) risk in a genetically defined population with a recent Acute Coronary Syndrome (ACS): The dal-GenE trial - dal-GenE
DalCor Pharma UK Ltd0 sites276 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Acute Coronary syndrome
- Sponsor
- DalCor Pharma UK Ltd
- Enrollment
- 276
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects with the appropriate genetic background and recently hospitalized for
- •ACS (between 1 and 3 months following the index event), will be enrolled in
- •this trial. ACS is defined as the occurrence of at least one of the following
- •A) Myocardial Infarction (MI)
- •Spontaneous MI \-\-\> A diagnosis of a qualifying MI event will be defined by a
- •rise and/or fall of cardiac biomarkers (preferably cardiac troponin) with at
- •least one determination greater than the 99th percentile upper reference limit
- •(URL) plus at least one of the following described below:
- •a. Symptoms of myocardial ischemia, or
- •b. New or presumed new significant ST\-segment\-T wave (ST\-T) changes or new left
Exclusion Criteria
- •1\. Females who are pregnant (negative pregnancy test required for all women of
- •child\-bearing potential at Visit 2, Day 0\) or breast\-feeding
- •2\. Women of child\-bearing potential (women who are not surgically sterile or
- •postmenopausal defined as amenorrhea for \>12 months) who are not using at least
- •one method of contraception.
- •3\. New York Heart Association (NYHA) Class III or IV heart failure
- •4\. Last known hemoglobin \<10g/dl
- •5\. Index ACS event presumed due to uncontrolled hypertension
- •6\. Systolic blood pressure (BP) \>180mmHg and/or diastolic blood pressure
- •\>110mmHg by the time of randomization despite anti\-hypertensive therapy
Outcomes
Primary Outcomes
Not specified
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