SB-480848 in Major Adverse Cardiovascular Events - Integrated Summary of Efficacy and Safety From the STABILITY Trial (LPL100601) and the SOLID-TIMI-52 Trial (SB-480848/033)
- Registration Number
- NCT01636271
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The overall objective of this integrated analysis is to evaluate the clinical safety and efficacy of long-term treatment with darapladib enteric coated tablets, 160mg, as compared to placebo when added to standard of care in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)). With respect to efficacy, the key purpose of this integrated analysis is to evaluate the effects of darapladib on the following endpoints: urgent coronary revascularization for myoacrdial ischemia, fatal/non-fatal stroke, time to subsequent Major Adverse Cardiovascular Event (MACE), and heart failure requiring hospitalization. The first occurrent of MACE, Major and total coronary events as well as the individual components of MACE will also be evaluated descriptively.
- Detailed Description
The objective of the integrated safety analysis is to characterize the safety profile of darapladib in subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) and post Acute Coronary Syndrome (ACS)).
The purpose of the integrated efficacy analysis is to test the effects of darapladib on select endpoints which are not part of the testing hierarchies associated with the individual studies, namely: urgent coronary revascularization for myocardial ischemia, stroke, subsequent MACE, and heart failure requiring hospitalization, For all other endpoints, the intent of the integrated analysis is to provide increased precision of the estimated effects of darapladib.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28855
- This is an integrated analysis therefore inclusion criteria are not applicable.
- This is an integrated analysis therefore exclusion criteria are not applicable.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1: subjects from LPL100601 placebo randomized subjects in study LPL100601 Group 2: subjects from SB480848/033 placebo randomized subjects in study SB480848/033 Group 1: subjects from LPL100601 darapladib randomized subjects in study LPL100601 Group 2: subjects from SB480848/033 darapladib randomized subjects in study SB480848/033
- Primary Outcome Measures
Name Time Method The time to first occurrence of urgent coronary revascularization for myocardial ischemia visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. time to the first occurrence of any urgent coronary revascularization for myocardial ischemia
The time to subsequent Major Adverse Cardiovascular Events (MACE) visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. time to subsequent composite of MACE (CV death, non-fatal MI or non-fatal stroke)
The time to first occurrence of stroke (fatal/non-fatal) visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. time to the first occurrence of stroke (fatal or non-fatal)
The time to first occurrence of heart failure requiring hospitalization visits occur at month 1,3,6, and every 6 months thereafter until 1500 first occurrence MACE events have occurred in each study. It is anticipated that the median follow-up time will be approximately 3 years in each study. time to the first occurrence of heart failure requiring hospitalization
- Secondary Outcome Measures
Name Time Method