Clinical trials: High Bleeding Risk (HBR)
Ischemic Heart Disease, Atrial Fibrillation
Anticoagulation on Demand After Percutaneous Coronary Intervention in High Bleeding Risk Patients
Preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation.
- Trial name
- INTERMITTENT (NCT04151680)
- Testing
- Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban, Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban
- Where
- 2 sites in Italy
- Volunteers
- 100 people
- Sponsor
- University of Roma La Sapienza
Coronary Artery Disease
Drug-Coated Balloon in Anticoagulated and Bleeding Risk Patients Undergoing PCI
The purpose of this study is to compare DCB with DES in stable CAD or ACS patients who are at high risk of bleeding. The hypothesis of the DEBATE trial is that the strategy using DCB and a shorter DAPT regimen is non-inferior to…
- Trial name
- DEBATE (NCT04814212)
- Testing
- Percutaneous coronary intervention using drug-coated balloon, Percutaneous coronary intervention using drug-eluting stent
- Where
- 14 sites in Finland, France and 2 more
- Volunteers
- 546 people
- Sponsor
- North Karelia Central Hospital
Coronary Disease, Heart Diseases
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…
- Conditions
- Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia
- Trial name
- PIV-EPIC (NCT06535568)
- Testing
- Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
- Where
- Italy
- Volunteers
- 576 people
- Sponsor
- Fondazione Ricerca e Innovazione Cardiovascolare ETS
Acute Coronary Syndrome
DAPT Strategy in HBR Patients Undergoing Complex PCI Following ACS: Second-Phase Beta Testing of a Patients Decision Aid
Among patients with acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI) and stent implantation, 17.5% are both at high bleeding risk (HBR) and have undergone complex PCI, which also places them at…
- Trial name
- BETA-DAPT (NCT07391358)
- Testing
- Patient decision aid to support shared decision-making between patients and clinicians
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Montreal Heart Institute
Coronary Artery Disease
Bioflow-DAPT Study
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx.
- Trial name
- NCT04137510
- Testing
- Percutaneous coronary intervention
- Where
- 53 sites in Australia, Austria and 16 more
- Volunteers
- 1,948 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Cruz HBR Registry - Post-market Registry to Evaluate the Safety and Efficacy of the Supraflex Cruz Stent
This is a prospective, multicenter, open-label, single-arm registry. The primary objective of this registry is to confirm the results of the Supraflex Cruz stent in real life all-comer patients (800 patients as in the Supraflex…
- Trial name
- NCT04138238
- Testing
- Supraflex Cruz Sirolimus-eluting Stent
- Where
- 26 sites in France, Germany and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Sahajanand Medical Technologies Limited
Dual Antiplatelet Therapy, Acute Coronary Syndrome
De-escalating Antiplatelet Therapy to Assess Platelet Reactivity and Outcomes in High Bleeding Risk Patients With Recent ACS
High bleeding risk (HBR) patients, comprising up to 50% of those presenting with acute coronary syndrome (ACS), are a high-risk group that is increasing in size due to an aging population.
- Conditions
- Dual Antiplatelet Therapy, Acute Coronary Syndrome, Coronary Artery Disease
- Trial name
- DESC-HBR (NCT05903976)
- Testing
- P2Y12 inhibitor de-escalation
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Bleeding Disorder, Stroke, Ischemic
XIENCE 28 Global Study
XIENCE 28 Global Study is a prospective, single arm, multi-center, open label, non-randomized trial to further evaluate the safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of…
- Conditions
- Bleeding Disorder, Stroke, Ischemic, Stroke Hemorrhagic, Hematological Disease
- Trial name
- NCT03355742
- Testing
- XIENCE, DAPT
- Where
- 52 sites in Austria, Belgium and 11 more
- Volunteers
- 963 people
- Sponsor
- Abbott Medical Devices
Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR)
Safety and Efficacy of De-escalation Dual Antiplatelet Therapy After BioFreedom™ Stenting in ACS Patients With Moderate-to-high Ischemic and High Bleeding Risk
Patients with acute coronary syndrome (ACS) who have both high ischemic risk and high bleeding risk represent a challenging population following percutaneous coronary intervention (PCI), as prolonged dual antiplatelet therapy…
- Conditions
- Acute Coronary Syndrome (ACS), High Bleeding Risk(HBR), Coronary Artery Disease (CAD)
- Trial name
- NCT07374718
- Testing
- IVUS-guided BioFreedomTM Drug-Coated Stent Implantation + 1-Month DAPT Followed by 11-Month P2Y12 Inhibitor Monotherapy, Angiography-guided Conventional Drug-Eluting Stent Implantation + 12-Month Dual Antiplatelet Therapy (Aspirin + P2Y12 Inhibitor)
- Where
- China
- Volunteers
- 468 people
- Sponsor
- Shenyang Northern Hospital
Coronary Artery Lesions
XIENCE 90: A Safety Evaluation of 3-month DAPT After XIENCE Implantation for HBR Patients.
XIENCE 90 study is a prospective, single arm, multi-center, open label trial to evaluate the safety of 3-month dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR) undergoing percutaneous coronary…
- Trial name
- NCT03218787
- Testing
- XIENCE, DAPT
- Where
- 101 sites in United States
- Volunteers
- 2,047 people
- Sponsor
- Abbott Medical Devices
Cardiac Disease, PCI
Comparison of the Supraflex Cruz 60 Micron Versus the Ultimaster Tansei 80 Micron in HBR PCI Population
The study compares the outcome of the ultrathin stent strut Supraflex Cruz stent to the thin stent strut Ultimaster Tansei stent in a PCI population at high risk for bleeding (HBR).
- Conditions
- Cardiac Disease, PCI, High Bleeding Risk
- Trial name
- NCT04500912
- Testing
- Supraflex Cruz 60 Micron, Ultimaster Tansei 80 Micron
- Where
- 11 sites in Netherlands
- Volunteers
- 736 people
- Sponsor
- Pieter C.Smits
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
Coronary Artery Disease
Drug-Coated Balloon in Patients With High Bleeding Risk
DCB-HBR trial is prospective, multi-center, open-label, randomized controlled, noninferiority trial. The aim of the study is to compare clinical outcomes of drug-coated balloon (DCB) with drug-eluting stent (DES) for treatment of…
- Trial name
- DCB-HBR (NCT05221931)
- Testing
- Percutaneous coronary intervention
- Where
- 17 sites in South Korea
- Volunteers
- 1,359 people
- Sponsor
- Samsung Medical Center
Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR)
Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy
Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype.
- Conditions
- Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR), Coronary Artery Disease (CAD)
- Trial name
- NCT07354828
- Where
- China
- Volunteers
- 3,500 people
- Sponsor
- Shenyang Northern Hospital
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), High Bleeding Risk
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…
- Trial name
- GUIDE-HBR (NCT06763744)
- Testing
- P2Y12 antagonist monotherapy, clopidogrel + aspirin
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- Samsung Medical Center
Bleeding Disorder, Ischemic Stroke
XIENCE 28 USA Study
The XIENCE 28 USA Study is prospective, single arm, multi-center, open label, non-randomized trial to evaluate safety of 1-month (as short as 28 days) dual antiplatelet therapy (DAPT) in subjects at high risk of bleeding (HBR)…
- Conditions
- Bleeding Disorder, Ischemic Stroke, Hemorrhagic Stroke, Hematological Diseases
- Trial name
- NCT03815175
- Testing
- XIENCE, DAPT (aspirin and/or P2Y12 receptor inhibitor)
- Where
- 111 sites in United States, Austria and 13 more
- Volunteers
- 1,605 people
- Sponsor
- Abbott Medical Devices
High Bleeding Risk, Coronary Artery Disease (CAD)
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing…
- Conditions
- High Bleeding Risk, Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
- Trial name
- DEBORA (NCT04885816)
- Testing
- Drug Eluting Balloon (DEB), Drug Eluting Stents (DES)
- Where
- Mexico
- Volunteers
- 5 people
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
High Bleeding Risk Patients, DAPT(Dual Antiplatelet Therapy)
OCT-based DAPT Cessation in HBR Patients
This study investigates whether patients with diabetes mellitus (DM) and a high risk of bleeding can safely stop dual antiplatelet therapy (DAPT) earlier than usual after receiving a special type of stent called a polymer-free…
- Conditions
- High Bleeding Risk Patients, DAPT(Dual Antiplatelet Therapy), Coronary Artery Disease, Diabetes Mellitus
- Trial name
- NCT07238764
- Testing
- Optical Coherence Tomography-based early DAPT discontinuation
- Where
- Russia
- Volunteers
- 40 people
- Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Coronary Stenosis
EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding.
- Trial name
- NCT03877848
- Testing
- Percutaneous Coronary Intervention (PCI)
- Where
- Israel
- Volunteers
- 319 people
- Sponsor
- Medinol Ltd.