Clinical Research Directory

Bivalirudin Versus Heparin During PCI in High Bleeding Risk Patients With Acute Coronary Syndromes

Background. Randomized data on the optimal parenteral anticoagulant during percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with acute coronary syndromes (ACS) are lacking. Methods. BRIGHT-HBR is an investigator-sponsored, open-label, randomized controlled trial comparing bivalirudin vs. unfractionated heparin (UFH) monotherapy in HBR patients with ACS undergoing PCI. A total of 5270 HBR patients with a non-ST-elevation acute coronary syndrome (NSTE-ACS) or recent stabilized ST-segment elevation myocardial infarction (STEMI, ≥48 hours after symptom onset) will be randomized 1:1 to bivalirudin or UFH at 70 sites in China. HBR is defined by the Academic Research Consortium (ARC)-HBR criteria. The primary composite endpoint is net adverse clinical events (NACE) at 30 days, the composite of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, or BARC types 2, 3 or 5 bleeding, and the major secondary endpoint is BARC types 2, 3 or 5 bleeding. The study is powered to demonstrate that bivalirudin is superior to UFH monotherapy for NACE in ACS patients with HRB at 30 days after PCI. Conclusions. The BRIGHT-HBR randomized trial aims to provide evidence on whether bivalirudin reduces the incidence of NACE and clinically relevant bleeding compared with UFH monotherapy in patients with ACS who are at HBR undergoing PCI.

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.

Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure

The goal of this clinical trial is to verify that Non-Antithrombotic Therapy (NAPT) followed by Oral Anticoagulants (OAC) monotherapy for 45 days after Left Atrial Appendage Closure (LAAC) is non-inferior to Single Antiplatelet Therapy (SAPT) with aspirin during the period from randomization to the end of observational period (4 years at the maximum) in non-valvular atrial fibrillation subjects with high bleeding risk. The primary endpoint is a composite endpoint consisting of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, or clinically relevant non-fatal bleeding from randomization to the end of study observation (up to a maximum follow-up of 4 years). * Participants will be enrolled in this study until the day following the implementation of LAAC and will be randomized to the SAPT arm and NAPT arm in a 1:1 ratio. * Participants will be observed for 4 years from the time the first subject is enrolled in this study. * Participants will visit the hospital at 45 days, 1 year, and 2 years after enrollment, and will also be followed up by telephone, basically at the end of the observation period (up to a maximum follow-up of 4 years). \<Study treatment duration\> In both arms, OAC monotherapy will be initiated in the first 24 hours of enrollment and continued for 45 days (allowed window period: plus 2 weeks).. * SAPT arm will continue to receive 45 days of OAC monotherapy followed by low-dose aspirin (75～100 mg/day) as an antithrombotic agent required through the end of the study observation period. * NAPT arm do not receive antithrombotic medication after 45 days of OAC monotherapy through the end of the study observation period.

Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR

The aim of this study is to assess the safety and efficacy of the CYP2C19 genotype-guided abbreviated dual antiplatelet therapy (DAPT) strategy versus the un-guided stepwise intensity de-escalation of DAPT strategy in patients with acute coronary syndrome (ACS) and high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI).

LEADERS FREE II: BioFreedom™ Pivotal Study

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.