Anticoagulation in Stent Intervention (MUSICA-2)
This study is ongoing, but not recruiting participants.
Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01141153
First received: June 9, 2010
Last updated: February 23, 2015
Last verified: February 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Stroke |
Drug: Acetylsalicylic Acid + clopidogrel + acenocoumarol Drug: Acetylsalicylic Acid + clopidogrel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
MedlinePlus related topics:
Atrial Fibrillation
U.S. FDA Resources
Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:
Primary Outcome Measures:
- A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death [ Time Frame: until 12 months ] [ Designated as safety issue: No ]Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment
Secondary Outcome Measures:
- Incidence of major and minor bleeding [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]
- Adverse events [ Time Frame: until 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 304 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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. |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01141153
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141153
Locations
| 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 | |
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Investigators
| Principal Investigator: | Antonia Sambola, MD Ph | |
| Study Director: | David García -Dorado, MD Ph |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT01141153 History of Changes |
| Other Study ID Numbers: | MUSICA-2 2009-017256-27 |
| Study First Received: | June 9, 2010 |
| Last Updated: | February 23, 2015 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
|
atrial fibrillation Coronary Stent implantation Low-moderate risk of stroke dual antiplatelet therapy anticoagulation |
Additional relevant MeSH terms:
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Clopidogrel Ticlopidine Aspirin Acenocoumarol 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 Fibrinolytic Agents Fibrin Modulating Agents Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors |
ClinicalTrials.gov processed this record on September 30, 2016