Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)Phase 4TIGER-BVSNCT02211066
TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization
A Phase 4 study testing Clopidogrel and Ticagrelor in people with Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion), run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)
- What is being tested?
- Clopidogrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesSpain
- Study dates
- Oct 2014to 12 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
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)
Read the 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 will test the role of ticagrelor/clopidogrel alone and together with ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is tested in the second randomization. The angiographic follow-up will be scheduled at 1 or 3-year follow-up in order to test the secondary hypothesis either at the moment of the end of the antiplatelet therapy or at the moment of scaffold bioresorption.
- Being tested
- Clopidogrel, Ticagrelor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClopidogrelDrug
TicagrelorDrug
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Active comparator | Clopidogrel 75 mg will be administered daily for 1 year Receives: Drug: Clopidogrel |
| Ticagrelor | Experimental | Ticagrelor 90 mg will be administered daily for 1 year Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 year
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 3 years
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.
Measured: 1 year
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.
Measured: 3 years
Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding.
Measured: 1 and 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionJun 2019
- Study completion12 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion)Studies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Juan A. Arnaiz, Hospital Clinic of Barcelona
- Investigators
- Salvatore Brugaletta, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211066
- Sponsor's protocol ID
- TIGER-BVS
- Other IDs
- 2013-002675-17
- Acronym
- TIGER-BVS
- Status last verified
- Dec 2019
- First submitted
- 28 Jul 2014
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34238679Brugaletta 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.
PubMed 28707316
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIcaGrEloR and ABSORB Bioresorbable Vascular Scaffold Implantation for Recovery of Vascular Function After Successful Chronic Total Occlusion Recanalization
- ClinicalTrials.gov ID
- NCT02211066
- Acronym / sponsor ID
- TIGER-BVS / TIGER-BVS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Oct 2014
- Primary completion
- Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 7 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 will test the role of ticagrelor/clopidogrel alone and together with ABSORB BVS implantation in the recovery of vascular function at long-term. This hypothesis is tested in the second randomization. The angiographic follow-up will be scheduled at 1 or 3-year follow-up in order to test the secondary hypothesis either at the moment of the end of the antiplatelet therapy or at the moment of scaffold bioresorption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Active comparator | Drug: ClopidogrelClopidogrel 75 mg will be administered daily for 1 year |
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor 90 mg will be administered daily for 1 year |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel | Drug | Clopidogrel |
| Ticagrelor | Drug | Ticagrelor |
Primary outcome
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.
Time frame: Baseline
11 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 1 year
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.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 3 years
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.
Time frame: 1 year
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.
Time frame: 3 years
Clinical endpoints at 1 and 3 years follow-up: cardiac death, probable or definite scaffold thrombosis, target vessel failure, bleeding.
Time frame: 1 and 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Derived from this study: PubMed 34238679Rodriguez-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.
- Derived from this study: PubMed 28707316Brugaletta 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salvatore Brugaletta, MD principal investigator
Hospital Clinic of Barcelona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel and Ticagrelor in people with Patients Who Are Scheduled to Undergo a PCI (Percutaneous Coronary Intervention) for CTO (Chronic Total Occlusion), run by Hospital Clinic of Barcelona at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02211066, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.