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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

The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality ( cardiovascular death resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke) in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene. Key secondary objectives of this trial are as listed below: Time to first occurrence of: The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for ACS (with ECG abnormalities) requiring coronary revascularization The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for ACS (with ECG abnormalities), or unanticipated coronary revascularization The composite of all cause death, resuscitated cardiac arrest, non-fatal MI, or non-fatal stroke Other secondary objectives of this trail are as listed below: Assessment of the long-term safety profile of dalcetrapib in this population Evaluation of the effects of dalcetrapib on lipids and hsCRP in this population Evaluation of the effects of dalcetrapib on: Evaluation to the effects of: The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for new or worsening heart failure The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke,hospitalization for ACS (with ECG abnormalities) requiring coronary revascularization, or hospitalization for new or worsening heart failure The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for new or worsening heart failure Fatal or non-fatal MI All-cause death

The primary objective of this trial is to evaluate the potential of dalcetrapib to reduce cardiovascular morbidity and mortality ( cardiovascular death resuscitated cardiac arrest, non-fatal myocardial infarction (MI) and non-fatal stroke) in subjects with a documented recent ACS and the AA genotype at variant rs1967309 in the ADCY9 gene. Key secondary objectives of this trial are as listed below: Time to first occurrence of: The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for ACS (with ECG abnormalities) requiring coronary revascularization The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, hospitalization for ACS (with ECG abnormalities), or unanticipated coronary revascularization The composite of all cause death, resuscitated cardiac arrest, non-fatal MI, or non-fatal stroke Other secondary objectives of this trail are as listed below: Assessment of the long-term safety profile of dalcetrapib in this population Evaluation of the effects of dalcetrapib on lipids and hsCRP in this population Evaluation of the effects of dalcetrapib on: Evaluation to the effects of: The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for new or worsening heart failure The composite of CV death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke,hospitalization for ACS (with ECG abnormalities) requiring coronary revascularization, or hospitalization for new or worsening heart failure The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI, non-fatal stroke, or hospitalization for new or worsening heart failure Fatal or non-fatal MI All-cause death