Subjects with coronary atherosclerosis (excluding ST segment-elevation MI [STEMI]) who require PCI (with or without stent). MedDRA version: 8.1 Level: LLT Classification code 10011093 Term: Coronary atherosclerosis
Conditions
Sponsors
The Medicines Company
Eligibility
Sex/Gender
All
Inclusion criteria
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 and one of the following: 2a. NSTEMI: Troponin I or T > upper limit of normal within 24-hours of randomization [or if troponin results are unavailable at that time, creatine kinase– myocardial band isoenzyme (CK-MB) > upper limit of normal] 2b. UA: Ischemic chest discomfort (angina or anginal equivalent) occurring at rest and lasting = 10 minutes within the 24 hours prior to randomization AND dynamic ECG changes† WITH either age= 65 years old and/or diabetes. 2c. STEMI: ECG changes including persistent [>20 minutes] ST-segment elevation in 2 or more contiguous leads) 3. Provide written informed consent before initiation of any study-related procedure 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
Exclusion criteria: 1 . Planned staged PCI procedure where the second stage will occur = 30 days after the first intervention 2 Admission planned for 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 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 15. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours (applicable to UA and NSTEMI patients)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to demonstrate that the efficacy of cangrelor (combined with usual care) is superior to that of usual care, in subjects requiring percutaneous coronary intervention (PCI) as measured by a composite of all-cause mortality, myocardial infarction (MI), and ischemia-driven revascularization (IDR).;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint is a composite incidence of all-cause mortality, MI, and IDR in the 48 hours after randomization. | — |
Countries
Czech Republic, Germany, Italy, Lithuania, Netherlands, Spain
Outcome results
None listed