Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Angina Pectoris Silent Ischemia |
Drug: Clopidogrel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy |
- Definite and/or probable stent thrombosis occurring between 6 and 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 4000 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Clopidogrel 6
6 month dual antiplatelet therapies in patients after second generation DES implantation
|
Drug: Clopidogrel
300-600 loading dose 75 mg/die for 6 months
|
|
Experimental: Clopidogrel 12
12 month dual antiplatelet therapies in patients after second generation DES implantation
|
Drug: Clopidogrel
300-600 loading dose 75 mg/die for 12 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Monica Repetto, Dr. | 02.34535088 ext 29 | repetto@mcr-med.com |
| Italy | |
| Irccs Fondazione Centro S. Raffaele Del Monte Tabor - | Recruiting |
| Milano (mi), Italy, 20132 | |
| Contact: Antonio Colombo, Dr. 02.26437331 colombo@emocolumbus.it | |
| Contact: Alaide Chieffo, Dr. 02.26437331 chieffo.alaide@hsr.it | |
| Principal Investigator: Maurizio Tespili, Dr. | |
| Principal Investigator: Gennaro Sardella, Prof. | |
| Principal Investigator: Patrizia Presbitero | |
| Principal Investigator: Giorgio Binetti, Dr. | |
| Principal Investigator: Cataldo Palmieri, Dr. | |
| Principal Investigator: Corrado Tamburino, Dr. | |
| Principal Investigator: Amerigo Stabile, Dr. | |
| Principal Investigator: Giuseppe Carosio, Prof. | |
More Information
No publications provided
| Responsible Party: | Marina Cornacchia Schenetti, Fondazione Evidence per Attività e Ricerche Cardiovascolari Onlus |
| ClinicalTrials.gov Identifier: | NCT00944333 History of Changes |
| Other Study ID Numbers: | Security |
| Study First Received: | July 22, 2009 |
| Last Updated: | July 22, 2009 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Fondazione Mediolanum per Attività e Ricerche Cardiovascolari Onlus:
|
second generation DES clopidogrel dual platelet therapy |
patients with documented silent ischemia unstable angina pectoris (Braunwald Classification) Diagnosis of angina pectoris (CCS) |
Additional relevant MeSH terms:
|
Angina Pectoris Ischemia Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Chest Pain Pain Signs and Symptoms Pathologic Processes Clopidogrel Ticlopidine Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 16, 2013