Patients with blocked blood vessels who have to have a balloon procedure known as a PCI to open the blocked vessels

• Conditions: Subjects with coronary atheroschlerosis who require PCI; MedDRA version: 15.0Level: LLTClassification code 10011076Term: Coronary artery atherosclerosisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2010-021591-28-AT
• Lead Sponsor: The Medicines Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-30
• Last Update Posted: 4 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10900

Inclusion Criteria

1.Male or non-pregnant female at least 18 years of age
2.Patients undergoing PCI:
a.Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
b.Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
c.STEMI patients (diagnostic angiography not required)
3.Provide written informed consent

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 7500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3000

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
5.Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); currently receiving warfarin; active bleeding
6.Impaired hemostasis: known international normalized ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand’s disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders); thrombocytopenia (platelet count <100,000/µL), or history of thrombocytopenia or neutropenia associated with clopidogrel
7.Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
8.Admission planned for <12 hours following PCI
9.Planned staged PCI procedure where the second stage will occur =30 days after the first intervention
10.Inability to give informed consent or comply with study related procedures, or high likelihood of being unavailable for follow-up
11.Known or suspected pregnancy, or lactating females
12.Allergy, hypersensitivity, or contraindication to aspirin, clopidogrel, cangrelor, mannitol, sorbitol, or microcrystalline cellulose
13.Active treatment with other investigational agents or devices at the time of randomization or planned use during the 30 day follow-up period
14.Previous enrollment in this trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified