Atherosclerosis Clinical Trial
— PlatformOfficial title:
A Clinical Trial Comparing Treatment With Cangrelor (in Combination With Usual Care) to Usual Care, 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 (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).
Status | Terminated |
Enrollment | 5364 |
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: 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. Exclusion Criteria: 1. Not a candidate for PCI 2. ST-segment elevation myocardial infarction (STEMI) within 48 hours of randomization 3. Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, intra-cranial tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery [including coronary artery bypass graft (CABG) surgery]; currently receiving warfarin, active bleeding 4. 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) at screening 5. Severe hypertension not adequately controlled by antihypertensive therapy at the time of randomization 6. Receipt of fibrinolytic therapy in the 12 hours preceding randomization 7. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding randomization 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] |
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 | Innovis Health | Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
The Medicines Company |
United States,
Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS, Goodman SG, White HD, Mahaffey KW, Pollack CV Jr, Manoukian SV, Widimsky P, Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington RA; CHAMPION PLA — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of All-cause Mortality, Myocardial Infarction (MI), and Ischemia-driven Revascularization (IDR) | mITT population; (composite incidence) | randomization through 48 hours post randomization | No |
Secondary | Incidence of All-cause Mortality or MI | mITT population | randomization through 48 hours post randomization | No |
Secondary | Incidence of All-cause Mortality | mITT population | randomization through 48 hours post randomization | No |
Secondary | Incidence of MI | mITT population | randomization through 48 hours post randomization | No |
Secondary | Incidence of IDR | mITT population | randomization through 48 hours post randomization | No |
Secondary | Incidence of Stent Thrombosis | mITT population | randomization through 48 hours post randomization | No |
Secondary | Incidence of Stroke | mITT | randomization through 48 hours post randomization | No |
Secondary | Incidence of All-cause Mortality | mITT population | randomization through 1 year post randomization | No |
Secondary | Incidence of Procedure Events [Abrupt Closure, Threatened Abrupt Closure, Need for Urgent Coronary Artery Bypass Graft (CABG) Surgery, Unsuccessful Procedure, New Thrombus or Suspected Thrombus, and/or Acute Stent Thrombosis] | mITT population A patient could have multiple procedural events. | During index PCI | No |
Secondary | Incidence of GUSTO Severe / Life-threatening | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours post randomization | Yes |
Secondary | Incidence of Thrombolysis in Myocardial Infarction (TIMI) Major | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours post randomization | Yes |
Secondary | Incidence of ACUITY Major Bleeding | Major bleeding (non-CABG-related) - Safety population | randomization through 48 hours post randomization | Yes |
Secondary | Incidence of ACUITY Major Bleeding Without Hematoma >/= 5 cm | Major bleeding (non-CABG-related) - Safety population excludes ACUITY major bleeding for which the only qualifying event was hematoma >/= 5 cm. | randomization through 48 hours post randomization | Yes |
Secondary | Incidence of All-cause Mortality, MI, or IDR | mITT population | randomization through 30 days post randomization | No |
Secondary | Incidence of All-cause Mortality or MI | mITT population | randomization through 30 days post randomization | No |
Secondary | Incidence of All-cause Mortality | mITT population | randomization through 30 days post randomization | No |
Secondary | Incidence of MI | mITT population | randomization through 30 days post randomization | No |
Secondary | Incidence of IDR | mITT population | randomization through 30 days post randomization | No |
Secondary | Incidence of Stent Thrombosis | mITT population | randomization through 30 days post randomization | No |
Secondary | Incidence of Stroke | mITT population | randomization through 30 days post randomization | No |
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