Overview

Anticoagulation in Stent Intervention

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital Universitari Vall d'Hebron Research Institute
Treatments:
Acenocoumarol
Aspirin
Clopidogrel
Ticlopidine
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.