Ticagrelor and preconditioning in patients with stable coronary artery disease (TAPER-S): a randomized pilot clinical trial.
Adolescent
Adult
Aged
Clinical Trials, Phase II as Topic
Clinical Trials, Phase III as Topic
Clopidogrel
/ administration & dosage
Coronary Artery Disease
/ surgery
Coronary Vessels
/ drug effects
Female
Fractional Flow Reserve, Myocardial
/ drug effects
Humans
Ischemic Preconditioning, Myocardial
/ methods
Male
Microvessels
/ drug effects
Middle Aged
Myocardial Reperfusion Injury
/ etiology
Percutaneous Coronary Intervention
/ adverse effects
Pilot Projects
Preoperative Care
/ methods
Purinergic P2Y Receptor Antagonists
/ administration & dosage
Randomized Controlled Trials as Topic
Ticagrelor
/ administration & dosage
Treatment Outcome
Vascular Resistance
/ drug effects
Young Adult
Adenosine
Angina
Clopidogrel
Fractional flow reserve
Intracoronary electrocardiography
Ischemic preconditioning
Microvascular dysfunction
Microvascular function
Microvascular resistance
Ticagrelor
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
17 Feb 2020
17 Feb 2020
Historique:
received:
04
04
2019
accepted:
29
01
2020
entrez:
19
2
2020
pubmed:
19
2
2020
medline:
15
12
2020
Statut:
epublish
Résumé
Ticagrelor is a reversibly binding, direct-acting, oral, P To determine whether ticagrelor can trigger ischemic preconditioning and influence microvascular function, we designed this prospective, open-label, pilot study that enrolled patients with stable multivessel CAD requiring staged, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI). Participants will be randomized in 1:1 ratios either to ticagrelor (loading dose (LD) 180 mg, maintenance dose (MD) 90 mg bid) or to clopidogrel (LD 600 mg, MD 75 mg) from 3 to 1 days before the scheduled PCI. The PCI operators will be blinded to the randomization arm. The primary endpoint is the delta (difference) between ST segment elevations (in millimeters, mm) as assessed by intracoronary electrocardiogram (ECG) during the two-step sequential coronary balloon inflation in the culprit vessel. Secondary endpoints are 1) changes in coronary flow reserve (CFR), index of microvascular resistance (IMR), and FFR measured in the culprit vessel and reference vessel at the end of PCI, and 2) angina score during inflations. This study started in 2018 with the aim of enrolling 100 patients. Based on the rate of negative FFR up to 30% and a drop-out rate up to 10%, we expect to detect an absolute difference of 4 mm among the study arms in the mean change of ST elevation following repeated balloon inflations. All study procedures were reviewed and approved by the Ethical Committee of the Catholic University of Sacred Heart. Ticagrelor might improve ischemia tolerance and microvascular function compared to clopidogrel, and these effects might translate to better long-term clinical outcomes. EudraCT No. 2016-004746-28. No. NCT02701140. TRIAL STATUS: Information provided in this manuscript refers to the definitive version (n. 3.0) of the study protocol, dated 31 October 2017, and includes all protocol amendments. Recruitment started on 18 September 2018 and is currently ongoing. The enrollment is expected to be completed by the end of 2019. Fondazione Policlinico Universitario A. Gemelli - Roma, Polo di Scienze Cardiovascolari e Toraciche, Largo Agostino Gemelli 8, 00168 Rome, Italy.
Sections du résumé
BACKGROUND
BACKGROUND
Ticagrelor is a reversibly binding, direct-acting, oral, P
METHODS
METHODS
To determine whether ticagrelor can trigger ischemic preconditioning and influence microvascular function, we designed this prospective, open-label, pilot study that enrolled patients with stable multivessel CAD requiring staged, fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI). Participants will be randomized in 1:1 ratios either to ticagrelor (loading dose (LD) 180 mg, maintenance dose (MD) 90 mg bid) or to clopidogrel (LD 600 mg, MD 75 mg) from 3 to 1 days before the scheduled PCI. The PCI operators will be blinded to the randomization arm. The primary endpoint is the delta (difference) between ST segment elevations (in millimeters, mm) as assessed by intracoronary electrocardiogram (ECG) during the two-step sequential coronary balloon inflation in the culprit vessel. Secondary endpoints are 1) changes in coronary flow reserve (CFR), index of microvascular resistance (IMR), and FFR measured in the culprit vessel and reference vessel at the end of PCI, and 2) angina score during inflations. This study started in 2018 with the aim of enrolling 100 patients. Based on the rate of negative FFR up to 30% and a drop-out rate up to 10%, we expect to detect an absolute difference of 4 mm among the study arms in the mean change of ST elevation following repeated balloon inflations. All study procedures were reviewed and approved by the Ethical Committee of the Catholic University of Sacred Heart.
DISCUSSION
CONCLUSIONS
Ticagrelor might improve ischemia tolerance and microvascular function compared to clopidogrel, and these effects might translate to better long-term clinical outcomes.
TRIAL REGISTRATION
BACKGROUND
EudraCT No. 2016-004746-28. No. NCT02701140. TRIAL STATUS: Information provided in this manuscript refers to the definitive version (n. 3.0) of the study protocol, dated 31 October 2017, and includes all protocol amendments. Recruitment started on 18 September 2018 and is currently ongoing. The enrollment is expected to be completed by the end of 2019.
TRIAL SPONSOR
UNASSIGNED
Fondazione Policlinico Universitario A. Gemelli - Roma, Polo di Scienze Cardiovascolari e Toraciche, Largo Agostino Gemelli 8, 00168 Rome, Italy.
Identifiants
pubmed: 32066489
doi: 10.1186/s13063-020-4116-7
pii: 10.1186/s13063-020-4116-7
pmc: PMC7027127
doi:
Substances chimiques
Purinergic P2Y Receptor Antagonists
0
Clopidogrel
A74586SNO7
Ticagrelor
GLH0314RVC
Banques de données
ClinicalTrials.gov
['NCT02701140']
Types de publication
Clinical Trial Protocol
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
192Subventions
Organisme : AstraZeneca SpA
ID : POR-TAP-16-007
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