A clinical trial comparing cangrelor to clopidogrel standard of care therapy in subjects who require percutaneous coronary intervention - Phoenix

Conditions: Subjects with coronary atherosclerosis who require PCI
MedDRA version: 9.1Level: LLTClassification code 10011076

Registration Number: EUCTR2010-021591-28-IT

Lead Sponsor: THE MEDICINES COMPANY

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10900

Inclusion Criteria

Patients with at least 18 years of age with stable angina (SA), acute coronary syndrome without ST-segment elevation (NSTE-ACS) and myocardial infarction with ST-segment elevation (STEMI) requiring ICP and who have not previously taken an inhibitor of P2Y12.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization; 2.Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered =12 hours prior to randomization); 3.Abciximab usage within 7 days preceding randomization; 4.Receipt of fibrinolytic therapy in the 12 hours preceding randomization

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to demonstrate that in patients requiring percutaneous coronary intervention (PCI), cangrelor provides superior efficacy to clopidogrel standard of care, as measured by a composite of all cause mortality, myocardial infarction (MI), ischemia-driven revascularization (IDR) and stent thrombosis.;Primary end point(s): The primary endpoint is the composite incidence of all cause mortality, MI, IDR and stent thrombosis, assessed 48 hours after randomization.;Secondary Objective: The main safety objective is to demonstrate that cangrelor has an acceptable safety profile without excessive periprocedural bleeding as measured by Thrombolysis in Myocardial Infarction (TIMI) scale compared to standard of care. <br>The value objective is to demonstrate that a lower use of healthcare resources is required to overcome limitations of irreversible platelet inhibition.

Secondary Outcome Measures