Anticoagulation in Stent Intervention (MUSICA-2)
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| ClinicalTrials.gov Identifier: NCT01141153 |
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Recruitment Status : Unknown
Verified February 2015 by Hospital Universitari Vall d'Hebron Research Institute.
Recruitment status was: Active, not recruiting
First Posted : June 10, 2010
Last Update Posted : February 24, 2015
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Objective:
The main objective is to evaluate the pattern of dual antiplatelet therapy (aspirin, 300 mg / day + clopidogrel 75 mg / day) compared to the use of the triple regimen (Acenocoumarol as control + acetylsalicylic acid 100 mg / day + Clopidogrel 75 mg / day) in patients with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2) who are undergoing PCI-S.
Design:
Randomized, parallel, with two arms, blind evaluation by third parties.
Patients:
304 patients undergoing PCI-S with atrial fibrillation, low-moderate risk of stroke (CHADS ≤ 2), which requires prevention of thrombosis
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atrial Fibrillation Stroke | Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol Drug: Acetylsalicylic Acid + clopidogrel | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 304 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Test of Efficacy and Safety of the Dual Antiplatelet Therapy Compared to the Combination of Oral Anticoagulant Therapy + Dual Antiplatelet Therapy in Patients With Atrial Fibrillation With Low-moderate Risk Submitted to Coronary Stent Implantation |
| Study Start Date : | June 2010 |
| Estimated Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Oral anticoagulation plus dual antiplatelet therapy |
Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol
Acetylsalicylic Acid 100 mg daily + Clopidogrel 75 mg daily + Acenocoumarol dosage with INR monitoring Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent |
| Active Comparator: Dual antiplatelet therapy |
Drug: Acetylsalicylic Acid + clopidogrel
Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent. |
- A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death [ Time Frame: until 12 months ]Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment
- Incidence of major and minor bleeding [ Time Frame: until 12 months ]
- Adverse events [ Time Frame: until 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients of both sexes older than 18 years.
- Patients with permanent atrial fibrillation, persistent or paroxysmal (at least one episode), documented electrocardiographically and receiving oral anticoagulation. Patients with acute coronary syndrome or stable angina who are undergoing PCI-S.
- Patients who have previously given their informed consent to participation in the study.
Exclusion Criteria:
- Patients who can not be followed by the research team during the 12 months provided for monitoring.
- Patients with renal failure or serum creatinine above 2 mg • dL-1, neurological deficits, active ulcer or epigastric pain.
- Patients who continue regular treatment with NSAIDs or other analgesics or corticosteroids.
- Patients undergoing reoperation.
- Patients who during the study period, should receive, according to medical criteria, other adjuvant drug treatment than that specified in this protocol.
- Pregnant women.
- Use of investigational agents or not registered within 30 days of entry into the study.
- Patients with a history of allergy to study drugs or excipients.
- Patients with severe valve disease.
- Patients with CHADS> 2.
- Patients who can not use the study drug orally.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141153
| Spain | |
| Hospital Germans Trias i Pujol | |
| Badalona, Barcelona, Spain, 08916 | |
| Hospital Universitari de Bellvitge | |
| Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
| Corporación Sanitaria Parc Taulí | |
| Sabadell, Barcelona, Spain, 08208 | |
| Hospital Marqués de Valdecilla | |
| Santander, Cantabria, Spain, 39011 | |
| Hospital Puerta del Hierro | |
| Majadahonda, Madrid, Spain, 28222 | |
| Hospital Sant Pau | |
| Barcelona, Spain, 08025 | |
| Hospital Universitario Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital Clínic de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital Dr.Josep Trueta | |
| Girona, Spain, 17007 | |
| Hospital Universitario Gregorio Marañón | |
| Madrid, Spain, 28007 | |
| Hospital San Carlos | |
| Madrid, Spain, 28040 | |
| Principal Investigator: | Antonia Sambola, MD Ph | ||
| Study Director: | David García -Dorado, MD Ph |
| Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT01141153 |
| Other Study ID Numbers: |
MUSICA-2 2009-017256-27 ( EudraCT Number ) |
| First Posted: | June 10, 2010 Key Record Dates |
| Last Update Posted: | February 24, 2015 |
| Last Verified: | February 2015 |
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atrial fibrillation Coronary Stent implantation Low-moderate risk of stroke dual antiplatelet therapy anticoagulation |
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Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes Aspirin Acenocoumarol Clopidogrel Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Anticoagulants |