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Sponsored by: |
Universitaria di Ferrara |
Information provided by: | Universitaria di Ferrara |
ClinicalTrials.gov Identifier: | NCT00611286 |
The duration of dual antiplatelet treatment (i.e. asprin and thienopyridines, mainly clopidogrel) after drug-eluting stent implantation is highly debated. This study will evaluate the value of extending such treatment up to 2 years after the procedure as compared to conventional treatment according to our national health institute guidelines (i.e. 1 month after bare metal stent and 6 months after drug-eluting stent) on the composite endpoint of death and MI.
Condition | Intervention | Phase |
Coronary Artery Disease |
Drug: clopidogrel treatment after bare metal stent implantation Drug: clopidogrel after zotarolimus-eluting stent implantation Drug: clopidogrel after paclitaxel-eluting stent implantation Drug: clopidogrel after everolimus-eluting stent implantation |
Phase IV |
MedlinePlus related topics: | Coronary Artery Disease Heart Attack |
ChemIDplus related topics: | Paclitaxel Everolimus Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | PROlonging Dual Antiplatelet Treatment In Patients With Coronary Artery Disease After Graded Stent-Induced Intimal Hyperplasia studY |
Estimated Enrollment: | 1000 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | December 2013 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
treatment with Aspirin and clopidogrel for 24 months after coronary intervention with stents. This group of patients will be randomized in a 1:1:1:1 ratio to receive bare metal stent, Zotarolimus-eluting stent, paclitaxel-eluting stent or everolimus-eluting stent.
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Drug: clopidogrel treatment after bare metal stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of bare metal stent
Drug: clopidogrel after zotarolimus-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of zotarolimus-eluting stent coronary implantation
Drug: clopidogrel after paclitaxel-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of paclitaxel-eluting stent
Drug: clopidogrel after everolimus-eluting stent implantation
extending use of clopidogrel on top of aspirin up to 24 months after coronary implantation of Everolimus-eluting stent
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2: Active Comparator
Treatment with aspirin and clopidogrel for 1 or 6 month(s) after BMS or DES implantation, respectively. This group of patients will be randomized in a 1:1:1:1 ratio to receive bare metal stent, Zotarolimus-eluting stent, paclitaxel-eluting stent or everolimus-eluting stent
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Drug: clopidogrel treatment after bare metal stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 1 month after BMS implantation.
Drug: clopidogrel after zotarolimus-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Drug: clopidogrel after paclitaxel-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
Drug: clopidogrel after everolimus-eluting stent implantation
Adding clopidogrel on top of Aspirin according to the practice suggested by Italian national institute of health, i.e. 6 month after DES implantation.
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This is a randomized, single-center, open-label, study to evaluate the efficacy and safety profile of prolonged dual antiplatelet treatment (i.e. up to 2-year) with aspirin and clopidogrel after coronary stenting compared to currently recommended antiplatelet regimens (i.e. dual antiplatelet treatment for 1 month after BMS or 6 months after DES implantation). As the degree of intimal hyperplasia (IH) suppression provided by the coronary stent system may be expected to influence the comparison between conventional versus prolonged dual antiplatelet treatment (DAT), patients in each group will be further randomized to no (BMS), intermediate (Endeavor), moderately high (Taxus) or very high (Xience V) degree of IH suppression so to minimize the confounding role of IH suppression on the primary hypothesis. Patients will be then follow-up on a clinical basis at 1, 6, 12, 18 and 24 months for the primary hypothesis and then every year up to five for secondary hypotheses.
In the conventional dual antiplatelet therapy group receiving one or more BMS implantation at the time of PCI, length of DAT may be influenced by acuity of clinical presentation. According to the CURE study (JAMA. 2002 Nov 20;288(19):2411-20), patients presenting with non-ST segment elevation acute coronary syndromes may be felt to require longer than 1 month DAT. Thus, to impose 1-month only of DAT duration after PCI may be not regarded as conventional at current stage. Based on this consideration, the protocol will allow extension of DAT up to 6 months after PCI in the conventional BMS group in those patients satisfying the inclusion and exclusion criteria of the CURE study at discretion of the treating physician.
Dual antiplatelet treatment refers to the use of Aspirin at doses ranging from 75 up to 325 mg/day p.o. in conjunction with clopidogrel (75 mg/day). Ticlopidine (250 mg/ twice a day) is a second-choice drug and it will be allowed in cases where clopidogrel is not well tolerated or unavailable. Clopidogrel and ticlopidine are equipotent antiplatelet agents. Both of them belong the class of thienopyridines and they act by inhibiting the the P2Y12 ADP receptor on platelets.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subjects with a contraindication to anticoagulation and/or increased bleeding risk:
Contact: Marco Valgimigli, MD, PhD | 00393356478877 | vlgmrc@unife.it |
Italy, Emilia Romagna | |||||
Azienda Ospedaliera Universitaria di Ferrara | Recruiting | ||||
Ferrara, Emilia Romagna, Italy, 44100 | |||||
Contact: Marco Valgimigli, MD, PhD 00393356478877 vlgmrc@unife.it |
Universitaria di Ferrara |
Principal Investigator: | Marco Valgimigli, MD, PhD | University of Ferrara, Italy |
Responsible Party: | Azienda Ospedaliera Universitaria di Ferrara ( Marco Valgimigli ) |
Study ID Numbers: | SSD-03-I |
First Received: | December 26, 2007 |
Last Updated: | June 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00611286 |
Health Authority: | Italy: Ethics Committee |
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