A clinical trial comparing treatment with cangrelor (in combinationwith usual care) to usual care, in subjects who require percutaneouscoronary interventionEnsayo clínico que compara el tratamiento con cangrelor (en combinación con el tratamiento habitual) en pacientes que necesitan un intervención coronaria percutánea. - Champion Platform
- Conditions
- Subjects with coronary atherosclerosis (excluding ST segment-elevationMI [STEMI]) who require PCI (with or without stent).Sujetos con ateroesclerosis coronaria (excluyendo el IM por elevación del segmento ST [STEMI]) que necesiten una ICP (con o sin endoprótesis vascular [Stent])MedDRA version: 8.1Level: LLTClassification code 10011093Term: Coronary atherosclerosis
- Registration Number
- EUCTR2006-003935-56-ES
- Lead Sponsor
- The Medicines Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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.
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
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
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