A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
This study has been completed.
Sponsor:
The Medicines Company
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01156571
First received: June 29, 2010
Last updated: January 9, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).
| Condition | Intervention | Phase |
|---|---|---|
|
Atherosclerosis Percutaneous Coronary Intervention Acute Coronary Syndrome |
Drug: cangrelor P2Y12 (platelet) inhibitor Drug: Clopidogrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX) |
Resource links provided by NLM:
MedlinePlus related topics:
Atherosclerosis
Drug Information available for:
Clopidogrel bisulfate
U.S. FDA Resources
Further study details as provided by The Medicines Company:
Primary Outcome Measures:
- A composite incidence of all-cause mortality, myocardial infarction, ischemia-driven revascularization and stent thrombosis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of stent thrombosis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
| Enrollment: | 11145 |
| Study Start Date: | September 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: cangrelor |
Drug: cangrelor P2Y12 (platelet) inhibitor
dosage as per standard of care
|
| Active Comparator: clopidogrel |
Drug: Clopidogrel
tablet
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients may be included in the study if they meet all of the following criteria:
- Male or non-pregnant female at least 18 years of age
Patients undergoing percutaneous coronary intervention (PCI):
- Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
- Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
- ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
- Provide written informed consent
Exclusion Criteria:
Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
- Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
- Abciximab usage within 7 days preceding randomization
- Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- 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
Contacts and Locations More Information
No publications provided by The Medicines Company
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT01156571 History of Changes |
| Other Study ID Numbers: | TMC-CAN-10-01 |
| Study First Received: | June 29, 2010 |
| Last Updated: | January 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cangrelor Atherosclerosis Acute Coronary Syndrome Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Myocardial Ischemia Heart Diseases Angina Pectoris Chest Pain Pain Signs and Symptoms |
Clopidogrel Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013