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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017256-27 | EudraCT Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral anticoagulation plus dual antiplatelet therapy | Experimental |
| |
| Dual antiplatelet therapy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic Acid + clopidogrel + acenocoumarol | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death | Incidence of the composite major events (stroke, myocardial infarction, systemic thromboembolism, stent thrombosis and death) until 12 months after the initial treatment | until 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major and minor bleeding | until 12 months | |
| Adverse events | until 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia Sambola, MD Ph | Principal Investigator | |
| David García -Dorado, MD Ph | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24093846 | Derived | Sambola A, Montoro JB, Del Blanco BG, Llavero N, Barrabes JA, Alfonso F, Bueno H, Cequier A, Serra A, Zueco J, Sabate M, Rodriguez-Leor O, Garcia-Dorado D. Dual antiplatelet therapy versus oral anticoagulation plus dual antiplatelet therapy in patients with atrial fibrillation and low-to-moderate thromboembolic risk undergoing coronary stenting: design of the MUSICA-2 randomized trial. Am Heart J. 2013 Oct;166(4):669-75. doi: 10.1016/j.ahj.2013.07.028. Epub 2013 Sep 14. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D000077144 | Clopidogrel |
| D000074 | Acenocoumarol |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Acetylsalicylic Acid + clopidogrel | Drug | Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent. |
|
| Barcelona |
| Barcelona |
| 08025 |
| Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Corporación Sanitaria Parc Taulí | Sabadell | Barcelona | 08208 | Spain |
| Hospital Marqués de Valdecilla | Santander | Cantabria | 39011 | Spain |
| Hospital Dr.Josep Trueta | Girona | Girona | 17007 | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | Madrid | 28007 | Spain |
| Hospital San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Puerta del Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Clínic de Barcelona | Barcelona | 08036 | Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |