- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00944333
Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
Prospective, randomized, non-inferiority, multicenter, international study.In total 4000 patients (70 centers in Europe) with de novo lesions in native coronary arteries who meet the eligibility criteria randomized to 6 versus 12 month dual antiplatelet therapies following a second generation DES implantation.
Assuming that the true proportion of thrombotic events is equal to 2.3% for both regimens (6-month and 12-month clopidogrel) 2000 patients for each treatment group are necessary to demonstrate a non-inferiority of the 6-months regimen if the proportion of thrombotic events will be no more than 3.5% with a power of 0.80 and a significance level of 0.05 (one-tail).
If the non-inferiority hypothesis will be rejected, the superiority hypothesis (12-months regimen is superior to the 6-months-regimen) will be tested at a significance level of 0.05 (two-tails).
The maximal not clinically relevant difference for the non-inferiority hypothesis of 1.2 % more thrombotic events has to be considered together with the lower expected number of bleeding events in the 6-months regimen.
All the analysis will be done as "intention-to-treat" analysis.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Milano (mi), Italy, 20132
- Irccs Fondazione Centro S. Raffaele Del Monte Tabor -
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent
- Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a Resolute drug eluting stent
- Patient is > 18 years of age (or minimum age as required by local regulations).
- The patient has consented to participate by signing the "Patient Informed Consent Form""
- The patient is willing and able to cooperate with study procedures and required follow up visits
- Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the exclusion criteria.
- At least one second generation DES implanted in the target lesion in the last 24 hours
- No other DES implanted before the target procedure
- No BMS implanted in the 12 months before the target procedure
Exclusion Criteria:
- Patients treated for lesions in venous or arterial grafts
- Patients treated for in-stent restenosis
- Patients treated for Unprotected Left Main lesions
- ST elevation myocardial infarction in the 48 hours prior to the procedure
- Non ST elevation myocardial infarction
- Patients with LVEF≤30%
- Women with known pregnancy or who are lactating
- Patients with hypersensitivity or allergies to hepari, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- Patients with chronic renal insufficiency
Contraindication to the use of clopidogrel and/or ASA:
- History of drug allergy to thienopyridine derivatives or ASA
- History of clinically significant or persistent thrombocytopenia or neutropenia
- Active bleeding or significant risk of bleeding, such as elderly patients receining fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
- Uncontrolled hypertension
- Current medical condition with a life expectancy of less than 24 months.
- The subject is participating in another device or drug study
- Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrolment in this trial.
- Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Clopidogrel 6
6 month dual antiplatelet therapies in patients after second generation DES implantation
|
300-600 loading dose 75 mg/die for 6 months
300-600 loading dose 75 mg/die for 12 months
|
Experimental: Clopidogrel 12
12 month dual antiplatelet therapies in patients after second generation DES implantation
|
300-600 loading dose 75 mg/die for 6 months
300-600 loading dose 75 mg/die for 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Definite and/or probable stent thrombosis occurring between 6 and 24 months
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of major adverse cardiac events (MACE) defined as the occurrence at 24 months of cardiac death, or myocardial infarction, or urgent target vessel revascularization (cardiac bypass surgery, or repeat PTCA)
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Ischemia
- Angina Pectoris
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Clopidogrel
Other Study ID Numbers
- Security
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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