A clinical trial comparing treatment with cangrelor (in combinationwith usual care) to usual care, in subjects who require percutaneouscoronary intervention - Champion Platform

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 6400

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.

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>IDR in the 48 hours after randomization.

Secondary Outcome Measures

Name	Time	Method

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