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)

NCT01636271 | Completed

• 1 other identifier: 116740
• Study Type: observational
• Target: 28,855
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Heart Disease

Keywords

CV Risk; Cardiovascular Disease; Atherosclerosis; Acute coronary syndrome

Outcome Measures

Primary Outcomes (4)

• The time to first occurrence of urgent coronary revascularization for myocardial ischemia

  time to the first occurrence of any 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.

• The time to first occurrence of stroke (fatal/non-fatal)

  time to the first occurrence of stroke (fatal or 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.

• The time to subsequent Major Adverse Cardiovascular Events (MACE)

  time to subsequent composite of MACE (CV death, non-fatal MI or non-fatal stroke)

  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.

• The time to first occurrence of heart failure requiring hospitalization

  time to the 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.

Study Arms (2)

Group 1: subjects from LPL100601

randomized subjects in study LPL100601

Drug: darapladib; Drug: placebo

Group 2: subjects from SB480848/033

randomized subjects in study SB480848/033

Drug: darapladib; Drug: placebo

Interventions

darapladib DRUG

darapladib enteric coated tablets 160 mg

Group 1: subjects from LPL100601; Group 2: subjects from SB480848/033

placebo DRUG

placebo

Group 1: subjects from LPL100601; Group 2: subjects from SB480848/033

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with clinical manifestations of cardiovascular disease (chronic coronary heart disease (CHD) or post Acute Coronary Syndrome (ACS)) randomized into the STABILITY trial (LPL100601) or the SOLID-TIMI 52 trial (SB-480848/033).

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Coronary Disease; Cardiovascular Diseases; Atherosclerosis; Acute Coronary Syndrome

Interventions

darapladib

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: July 10, 2012
• Study Start: October 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 3, 2014

Record last verified: 2014-10