The use of antiplatelet drug (Ticagrelor) and bioresorbable coronary stent in recovery of vascular function after successful coronary recanalization.

Phase 1

• Conditions: Chronic total coronary occlusion; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-002675-17-ES
• Lead Sponsor: Fundació Clínic per a la Recerca Biomèdica

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-22
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

a.Patients of both sexes, more than 18 years old.
b. Written informed consent obtained.
c. 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.
d. Patients eligible for coronary revascularization in a coronary chronic total occlusion, which was angiographically documented in a previous coronary angiography during the last year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

Exclusion Criteria

a. Women who are pregnant or women of childbearing potential who do not use adequate contraception.
b. Known allergies to aspirin, clopidogrel bisulfate (Plavix ®), ticagrelor (BriliqueTM) heparin, or a sensitivity to contrast media, which cannot be adequately pre-medicated.
c. Participation in other studies.
d. Life expectancy of less than one year or factors making clinical and/or angiographic follow-up difficult.
e. Planned cardiac surgery or major non-cardiac surgery.
f. The subject has a history of bleeding diathesis or coagulopathy.
g. The subject suffered disabling stroke within the past year.
h. 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.
i. 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.
j. Inability to provide informed consent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified