A clinical trial comparing cangrelor to clopidogrel in subjects who require percutaneous coronary intervention. - ND

• Conditions: Subjects with coronary atherosclerosis who require PCI (with or without stent).; MedDRA version: 6.1Level: PTClassification code 10011076

• Registration Number: EUCTR2006-000192-14-IT
• Lead Sponsor: THE MEDICINES COMPANY UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 9000

Inclusion Criteria

1. Male or non-pregnant female at least 18 years of age 2. Diagnostic coronary angiography demonstrating atherosclerosis amenable to treatment by PCI with or without stent implantation 3. Provide written informed consent before initiation of any study-related procedure Importantly, the treating physician must have knowledge of the coronary anatomy and suitability for PCI prior to randomization, except for patients diagnosed with STEMI. Due to the compelling nature of STEMI and the high likelihood of a percutaneous intervention, these subjects may be randomized on diagnosis, preferably in the emergency department, provided there is no impediment to primary PCI.
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 . Planned staged PCI procedure where the second stage will occur <= 30 days after the first intervention 2 Admission planned for <12 hrs following PCI 3 Known or suspected pregnancy, or lactating females 4. 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 5. 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/?L), or history of thrombocytopenia or neutropenia associated with clopidogrel 6. 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) 7. Receipt of fibrinolytic therapy in the 12 hours preceding randomization 8. Receipt of a clopidogrel dose exceeding the maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization (subjects receiving chronic clopidogrel therapy at a dose of 75 mg are eligible) 9. Not a candidate for PCI 10. Inability to swallow study capsules 11. Allergy, hypersensitivity, or contraindication to clopidogrel, cangrelor, mannitol, sorbitol, or microcrystalline cellulose 12. Treatment with other investigational agents or devices within the 30 days preceding randomization, planned use of investigational drugs or devices, or previous enrollment in this trial 13. Known alcohol or illicit substance abuse 14. Inability to give informed consent or high likelihood of being unavailable for follow-up

Study & Design

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