Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion) Clinical Trial
— TIGER-BVSOfficial title:
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization
| Verified date | December 2019 |
| Source | Hospital Clinic of Barcelona |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 (chronic total occlusion - percutaneous coronary intervention)
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | June 12, 2019 |
| Est. primary completion date | June 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Clínic de Barcelona | Barcelona | |
| Spain | Hospital Universitari de Bellvitge | Hospitalet de Llobregat | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Clinic of Barcelona | AstraZeneca |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Differences in increase of coronary blood flow (CBF) under adenosine administration from baseline in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group. | Baseline | ||
| Secondary | Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group. | Baseline | ||
| Secondary | Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted immediately after CTO-PCI between the ticagrelor vs. clopidogrel group. | Baseline | ||
| Secondary | Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 1 year follow-up between the ticagrelor vs. clopidogrel group. | 1 year | ||
| Secondary | Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group | 1 year | ||
| Secondary | Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 1-year follow-up between the ticagrelor vs. clopidogrel group. | 1 year | ||
| Secondary | Changes from baseline in mean lumen diameter after nitrate administration in the coronary segment scaffolded by ABSORB and in that distal to it at 3-year follow-up between the ticagrelor vs. clopidogrel group. | 3 years | ||
| Secondary | Changes from baseline in coronary blood flow after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group. | 3 years | ||
| Secondary | Changes from baseline in coronary flow reserve after adenosine administration in the coronary segment distal to the scaffold implanted at 3-year follow-up between the ticagrelor vs. clopidogrel group. | 3 years | ||
| Secondary | Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography in a subgroup of patients at 1-year follow-up between the ticagrelor vs. clopidogrel group. | 1 year | ||
| Secondary | Difference in intimal-media thickness at the site of scaffold implanted, evaluated by optical coherence tomography at 3 years follow-up between the ticagrelor vs. clopidogrel group. | 3 years | ||
| Secondary | Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding. | 1 and 3 years |