Status:
COMPLETED
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization
Lead Sponsor:
Hospital Clinic of Barcelona
Collaborating Sponsors:
AstraZeneca
Conditions:
Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is a single-centre, randomized, active controlled, open label clinical trial. The primary hypothesis is that ticagrelor will show superiority over clopidogrel immediately after CTO-PCI (chro...
Detailed Description
The hypothesis is tested in the first randomization. Both antiplatelet therapy will be used in both arms at the approved doses and for the approved duration therapy of 1-year. The secondary hypothesis...
Eligibility Criteria
Inclusion
- Patients of both sexes, older than 18 years old.
- Written informed consent obtained.
- Patients with stable angina pectoris (Canadian Cardiovascular Society (CCS) Class 1, 2, 3 or 4) or patients with documented silent ischemia by stress test during the last year.
- Patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year.
Exclusion
- Women who are pregnant or women of childbearing potential who do not use adequate contraception.
- Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
- Participation in other studies.
- Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
- Planned cardiac surgery or major non-cardiac surgery.
- The subject has a history of bleeding diathesis or coagulopathy.
- The subject suffered disabling stroke within the past year.
- Known major hematologic, neoplastic, metabolic, gastrointestinal or endocrine dysfunction, which, in the judgment of the Investigator, may affect the patient's ability to complete the study.
- History of malignancy, except in patients who have been disease-free \>5 years or whose only malignancy has been basal or squamous cell skin carcinoma.
- Inability to provide informed consent
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2019
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT02211066
Start Date
October 1 2014
End Date
June 12 2019
Last Update
December 19 2019
Active Locations (2)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Hospital Clínic de Barcelona
Barcelona, Spain, 08036