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van CCT (UK)

van CCT (UK)

Antiplatetelet therapy in patients with acute coronary syndromes undergoing percutaneous coronary intervention.

- candidate number13798
- NTR NumberNTR3704
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2012
- Secondary IDsMEC-2010-417 METC Erasmus MC
- Public TitleAntiplatetelet therapy in patients with acute coronary syndromes undergoing percutaneous coronary intervention.
- Scientific TitleAntiplatetelet therapy in PCI-treated ACS patients: The Rijnmond Collective Cardiology Research (CCR) Observational Study.
- hypothesisThe primary objective of the CCR study is to monitor clinically relevant parameters of ACS patients undergoing PCI with a follow-up of 1 year, after updating treatment guidelines of the participating network to include prasugrel as the first line treatment option for antiplatelet therapy.
- Healt Condition(s) or Problem(s) studiedAcute coronary syndrome (ACS)
- Inclusion criteria1. Diagnosis with NSTE-ACS or STEMI and treated with PCI during index hospitalization;
2. Age above 18 years.
- Exclusion criteriaIntolerance or allergy for aspirin, ticlopidine, clopidogrel or prasugrel.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2011
- planned closingdate1-jun-2014
- Target number of participants4000
- InterventionsThere is no treatment intervention directed by the protocol in the CCR study. All treatment decisions are at the discretion of the treating physician in accordance with practice guideline recommendations and local standards practice. There will be post-hoc comparisons of prasugrel with historic clopidogrel-treated patients with regard to the occurrence of a combined endpoint through 1 year.
- Primary outcomeComposite of all-cause mortality and nonfatal myocardial infarction.
- Secondary outcome1. All cause mortality;
2. Cardiovascular death;
3. Non fatal myocardial infarction;
4. Stroke;
5. Target vessel revascularization (TVR);
6. Stent thrombosis;
7. MACE (CV death/non-fatal MI/TVR);
8. Incidence of non-CABG-related TIMI major bleeding.
- Timepoints1 month and 12 months.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Marc M.J.M. Linden, van der
- Sponsor/Initiator Eli Lilly Nederland
- Funding
(Source(s) of Monetary or Material Support)
Eli Lilly Nederland B.V., Daiichi Sankyo
- PublicationsN/A
- Brief summaryThe CCR registry is a prospective, multicenter, observational study that will follow up to 4,000 ACS patients managed with PCI, from the in-hospital to outpatient settings for up to 12 months post-discharge for longitudinal assessment of outcomes associated with the adoption of prasugrel into routine clinical practice. This registry exemplifies a collaborative study design that employs a regional PCI registry platform and will provide important real-world clinical data.
- Main changes (audit trail)
- RECORD14-nov-2012 - 1-dec-2012

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