TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization

NCT02211066 | Completed Phase 4

• 2 other identifiers: TIGER-BVS2013-002675-17
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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 (chronic total occlusion - percutaneous coronary intervention)

Conditions

Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Clopidogrel

ACTIVE COMPARATOR

Clopidogrel 75 mg will be administered daily for 1 year

Drug: Clopidogrel

Ticagrelor

EXPERIMENTAL

Ticagrelor 90 mg will be administered daily for 1 year

Drug: Ticagrelor

Interventions

Clopidogrel DRUG

Clopidogrel

Ticagrelor DRUG

Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• AstraZeneca: collaborator

Study Sites (2)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (2)

• Rodriguez-Arias JJ, Gomez-Lara J, Caballero-Borrego J, Ortega-Paz L, Arevalos V, Teruel L, Gil-Jimenez T, Oyarzabal L, Romaguera R, Moreno-Terribas G, Gomez-Hospital JA, Sabate M, Brugaletta S. Long-Term Vascular Function in CTO Recanalization: A Randomized Clinical Trial of Ticagrelor vs. Clopidogrel. Cardiovasc Revasc Med. 2022 Apr;37:61-67. doi: 10.1016/j.carrev.2021.06.129. Epub 2021 Jul 1.

  PMID: 34238679 DERIVED

• Brugaletta S, Gomez-Lara J, Caballero J, Ortega-Paz L, Teruel L, Jimenez Fernandez M, Romaguera R, Alcalde Martinez V, Nato M, Molina Navarro E, Gomez-Hospital JA, Correa Vilches C, Joyera M, Cequier A, Sabate M. TIcaGrEloR and Absorb bioresorbable vascular scaffold implantation for recovery of vascular function after successful chronic total occlusion recanalization (TIGER-BVS trial): Rationale and study design. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):1-6. doi: 10.1002/ccd.27196. Epub 2017 Jul 14.

  PMID: 28707316 DERIVED

MeSH Terms

Interventions

Clopidogrel; Ticagrelor

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Salvatore Brugaletta, MD

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Manager

Study Record Dates

• First Submitted: July 28, 2014
• First Posted: August 7, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: June 12, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Locations

ES (2)