Anticoagulation in Stent Intervention
| Conditions | Phase | Intervention Type |
|---|---|---|
| Phase 4 |
|
Eligibility
- Ages Eligible for Study
- 18 years and up
- Genders Eligible for Study
- Both
Keywords
atrial fibrillation, Coronary Stent implantation, Low-moderate risk of stroke, dual antiplatelet therapy, and anticoagulation
Sponsors
- Other
- Hospital Universitari Vall d'Hebron Research Institute
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.
Detailed Description
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01141153
Overall Contact
Overall Contact Backup
Locations
-
Hospital Sant PauBarcelona, Spain(Recruiting)
Contact info
Antoni Serra, MD Ph -
Hospital Puerta del HierroMajadahonda, Madrid Spain(Recruiting)
Contact info
Javier Goicolea, MD Ph -
Hospital Universitario Vall d'HebronBarcelona, Spain(Recruiting)
Contact info
Nadia Llavero34934894031nadiallavero@gmail.com Antonia Sambola, MD Ph34932746000x3714asambola@yahoo.es -
Hospital Germans Trias i PujolBadalona, Barcelona Spain(Recruiting)
Contact info
Oriol Rodríguez, MD Ph -
Hospital Universitari de BellvitgeHospitalet de Llobregat, Barcelona Spain(Recruiting)
Contact info
Ángel Cequier, MD Ph -
Hospital Marqués de ValdecillaSantander, Cantabria Spain(Recruiting)
Contact info
Javier Zueco, MD Ph
-
Hospital Clínic de BarcelonaBarcelona, Spain(Not yet recruiting)
Contact info
Manuel Sabaté, MD Ph -
Hospital Dr.Josep TruetaGirona, Spain(Recruiting)
Contact info
Martí Puigfel, MD Ph -
Hospital San CarlosMadrid, Spain(Recruiting)
Contact info
Fernando Alfonso, MD Ph -
Hospital Universitario Gregorio MarañónMadrid, Spain(Recruiting)
Contact info
Héctor Bueno, MD Ph