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XienceV stent vs Cypher stent in primary PCI for acute myocardial infarction.


- candidate number2869
- NTR NumberNTR1123
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-nov-2007
- Secondary IDsABR NL17690.0099.07 Diagr. 9056 XAMI
- Public TitleXienceV stent vs Cypher stent in primary PCI for acute myocardial infarction.
- Scientific TitleXienceV stent vs Cypher stent in primary PCI for acute myocardial infarction; a randomized trial.
- ACRONYMXAMI
- hypothesisEssess the effectiveness of the Xience stent compared to the CYPHHER stent in the treatment of acute myocardial infarction patients.
- Healt Condition(s) or Problem(s) studiedAcute myocardial infarction
- Inclusion criteria1. Patients with acute ST elevated myocardial infarction;
2. Patient is willing to perform all follow-up examination as required by the protocol;
3. Patient is eligible for coronary revascularization intervention by PCI and stenting;
4. Patient is located in a geographic area that will enable contact by study site follow-up.
- Exclusion criteria1. Chronical total occlusion as target lesion intervention;
2. stent thrombosis or previous stent at target lesion;
3. drug,-alcohol abusers or prisoners;
4. allergic to everolimus or sirolimus;
5. intolerance or contra-indicated to treatment with acetylsalicylic acid or clopidogrel;
6. over 80 years old;
7. stent implantation not possible, judged by cardiologist;
8. intubated patients;
9. life expectancy < 1 year;
10. stent size >3.5 mm required to treat lesion.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupFactorial
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2007
- planned closingdate1-jun-2012
- Target number of participants800
- InterventionsPCI with stent placement.
- Primary outcomeClinical MACE at 1 year (cardiac mortality, non-fatal myocardial infarction, TVR.
- Secondary outcome1. (Sub)-acute stent thrombosis (SAT) at 30 days and late stent thrombosis (LST) at 1, 2 and 3 year;
2. Clinical MACE at 30 days and 2 and 3 year (cardiac death, non fatal MI, TVR);
3. All cause mortality at 1,2 and 3 year.
- Timepoints18 month enrolment and 36 month follow-up.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES J. Klijn
- CONTACT for SCIENTIFIC QUERIES J. Klijn
- Sponsor/Initiator Medisch centrum Leeuwarden, cardiologie poli 67
- Funding
(Source(s) of Monetary or Material Support)
Abbott, Cordis NL
- PublicationsN/A
- Brief summaryThis is a prospective randomized multi-center study designed to assess clinical performance of the Xience stent in AMI patients compaired to the CYPHER. The patient will undergo a clinical examination to assess their clinival status and the occurrence of adevrse clinical events before and after the procedure and follow-up at 30 days, 1, 2 and 3 years after the procedure.
- Main changes (audit trail)
- RECORD9-nov-2007 - 3-apr-2008


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