EUCTR2006-003935-56-ITActive, not recruitingNot Applicable
A clinical trial comparing treatment with cangrelor (in combination with usual care) to usual care, in subjects who require percutaneous coronary intervention - Champion Platform
THE MEDICINES COMPANY UK0 sites6,400 target enrollmentStarted: May 5, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 6,400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
- •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
- •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. ST-segment elevation MI within 48 hours of randomization
- •4. Known or suspected pregnancy, or lactating females
- •5. 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
- •CABG surgery); currently receiving warfarin, active bleeding
- •6. 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
- •7. Severe hypertension not adequately controlled by antihypertensive therapy at the
- •time of randomization (systolic blood pressure >180mm Hg or diastolic blood
- •pressure >110 mm Hg)
- •8. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- •9. Receipt of any thienopyridine (clopidogrel or ticlopidine) in the 7 days preceding
- •randomization
- •10. Not a candidate for PCI
- •11. Allergy, hypersensitivity, or contraindication to cangrelor, mannitol or sorbitol
- •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, comply with study related procedures, or high
- •likelihood of being unavailable for follow-up
- •15. Glycoprotein IIb/IIIa Inhibitor (GPI) usage within the previous 12 hours
- •(applicable to UA and 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.
Investigators
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