Myocardial Infarction (MI) Clinical Trial
— PCIOfficial title:
A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention (PCI).
Verified date | April 2014 |
Source | The Medicines Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this study is to demonstrate that the efficacy of cangrelor is superior, or at least non-inferior, to that of clopidogrel in subjects requiring PCI.
Status | Terminated |
Enrollment | 8882 |
Est. completion date | June 2010 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
INCLUSION CRITERIA To be included in this study, subjects must meet the following criteria: - Angiography demonstrating atherosclerosis amenable to treatment by percutaneous coronary intervention (PCI) with or without stent implantation and diagnosis of Acute Coronary Syndrome (ACS) by elevated cardiac markers or ischemic chest discomfort w/electrocardiogram changes + age > 65 or diabetes or ST-elevation MI. EXCLUSION CRITERIA Subjects will be excluded from the study if they present with any of the following: 1. Not a candidate for PCI 2. 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 by-pass surgery); currently receiving warfarin, active bleeding 3. Impaired hemostasis: known International Normalized Ratio (INR) >1.5 at screening; 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 4. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization 5. Receipt of fibrinolytic therapy in the 12 hours preceding randomization 6. Receipt of clopidogrel dose exceeding maintenance dose (ie, >75 mg) at any time in the 5 days preceding randomization 7. Inability to swallow study capsules 8. Glycoprotein IIb/IIIa (GPI) Inhibitor usage within the previous 12 hours [applicable to unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) patients] Subjects excluded for any of the above reasons may be re-screened for participation at any time if the exclusion characteristic has changed. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
The Medicines Company |
United States,
Harrington RA, Stone GW, McNulty S, White HD, Lincoff AM, Gibson CM, Pollack CV Jr, Montalescot G, Mahaffey KW, Kleiman NS, Goodman SG, Amine M, Angiolillo DJ, Becker RC, Chew DP, French WJ, Leisch F, Parikh KH, Skerjanec S, Bhatt DL. Platelet inhibition — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | (composite incidence) | randomization through 48 hours after randomization | No |
Secondary | Incidence of All-cause Mortality and MI | (composite incidence) | randomization through 48 hours after randomization | No |
Secondary | Individual Incidence of All-cause Mortality | randomization through 48 hours after randomization | No | |
Secondary | Individual Incidence of IDR | randomization through 48 hours after randomization | No | |
Secondary | Incidence of Stroke | Stroke is defined as a sudden, focal neurological defect resulting from a cerebrovascular cause that is not reversible within 24 hours and not due to a readily identifiable cause such as a tumor or trauma. All suspected strokes were reviewed and adjudicated by the Clinical Events Committee (CEC) who considered all clinically relevant information and imaging studies to classify all strokes as: primary hemorrhagic - stroke with focal collections of intracranial blood ischemic cerebral infarction - stroke without focal collections of intracranial blood infarction with hemorrhagic conversion - cerebral infarction with blood thought to represent hemorrhagic conversion and not primary bleeding uncertain - no imaging or autopsy data are available. |
randomization through 48 hours after randomization | No |
Secondary | Incidence of Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, or Unsuccessful Procedure During the Index PCI | (a patient could have multiple procedural events) | during index PCI | No |
Secondary | Incidence of All-cause Mortality, MI or IDR | (composite incidence) | randomization through 30 days after randomization | No |
Secondary | Incidence of All-cause Mortality or MI | (composite incidence) | randomization through 30 days after randomization | No |
Secondary | Incidence of All-cause Mortality | randomization through 30 days after randomization | No | |
Secondary | Incidence of MI | randomization through 30 days after randomization | No | |
Secondary | Incidence of IDR | randomization through 30 days after randomization | No | |
Secondary | Incidence of Stroke | randomization through 30 days after randomization | No | |
Secondary | Incidence of All Cause Mortality | (excluding STEMI) | randomization through 1 year after randomization | No |
Secondary | Incidence of GUSTO Severe / Life-threatening Bleeding | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours after randomization | Yes |
Secondary | Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours after randomization | Yes |
Secondary | Incidence of ACUITY Major Bleeding | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours after randomization | Yes |
Secondary | Incidence of ACUITY Major Bleeding (Without Hematoma >/= 5 cm) | excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm | randomization through 48 hours after randomization | Yes |
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