Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Selective PCI
Bivalirudin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease
Eligibility Criteria
Inclusion Criteria:
- ≥ 65 years, with diabetes mellitus.
- Patients who undergo selective PCI therapy.
- Patients who agree to participate in this clinical trial and sign informed consent prior to surgery.
Exclusion Criteria:
- Patients with acute coronary syndrome undergoing primary PCI.
- Combined with other diseases, the life expectancy of patients don't exceed 1 year.
- Patients with active bleeding.
- Bleeding in the gastrointestinal or urogenital tract in the past 6 weeks.
- Combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc.
- Patients who have undergone major surgery in the last 1 month.
- A history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms.
- Patients with cardiogenic shock, or suspected myocarditis, infective endocarditis.
- Patients who received regular heparin therapy within 6 hours or low molecular weight heparin therapy within 8 hours, or other factors that the researchers believe may influence the outcome of the trial.
- Patients with severe uncontrolled hypertension.
- Patients with active hepatitis, HIV and other infectious diseases.
- Patients with contraindications of bivalirudin and heparin.
- Other researchers considered the patients are unfit to participate in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Selective PCI with bivalirudin
Unfractionated heparin
Arm Description
Before PCI, bivalirudin is intravenously injected with 0.75 mg/kg, 1.75 mg/(kg.h) through continuous intravenous drip to finish surgery (no more than 4 hours), if necessary, after the surgery, with a low dose of 0.2 mg/(kg.h) intravenous drip less than 20 hours.
Before PCI, unfractionated heparin sodium is intravenously injected with 70-100 U/kg, and if the operation time exceeded 1h, an additional 1000 U/h would be added.
Outcomes
Primary Outcome Measures
activated clotting time(ACT)
The ACT test can be used to monitor anticoagulation effects, such as high-dose heparin before, during, and shortly after procedures that require intense anticoagulant administration, such as cardiac bypass, cardiac angioplasty, thrombolysis, extra-corporeal membrane oxygenation (ECMO) and continuous dialysis
Secondary Outcome Measures
30-day major adverse cardiac events
30-day major adverse cardiac events including recidivation of angina pectoris, in-stent restenosis, severe arrhythmia, cardiac failure, sudden cardiac death.
30-day bleeding events
According to the bleeding academic research consortium (BARC) bleeding classification.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03567408
Brief Title
Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)
Official Title
Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention (PCI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2018 (Anticipated)
Primary Completion Date
August 12, 2019 (Anticipated)
Study Completion Date
August 12, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Qian Gong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Bivalirudin is widely used as an anticoagulant to reduce the risk of bleeding in PCI perioperative period. Additionally, 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI), so bivalirudin was used to anticoagulate in these patients to evaluate its safety and efficacy.
Detailed Description
Bivalirudin is a specific reversible thrombin direct inhibitor and the function of thrombin activity site can be recovered through hydrolyzing bivalirudin by thrombin. Therefore, bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease, and 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI). At the same time, elderly patients have higher risk of bleeding whose age over 65, so bivalirudin can reduce the risk of bleeding and the incidence of net adverse clinical events for the elderly patients whose age over 65 with diabetes mellitus in PCI perioperative period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selective PCI with bivalirudin
Arm Type
Experimental
Arm Description
Before PCI, bivalirudin is intravenously injected with 0.75 mg/kg, 1.75 mg/(kg.h) through continuous intravenous drip to finish surgery (no more than 4 hours), if necessary, after the surgery, with a low dose of 0.2 mg/(kg.h) intravenous drip less than 20 hours.
Arm Title
Unfractionated heparin
Arm Type
Placebo Comparator
Arm Description
Before PCI, unfractionated heparin sodium is intravenously injected with 70-100 U/kg, and if the operation time exceeded 1h, an additional 1000 U/h would be added.
Intervention Type
Procedure
Intervention Name(s)
Selective PCI
Intervention Description
Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus.
Intervention Type
Drug
Intervention Name(s)
Bivalirudin
Other Intervention Name(s)
Angiomax
Intervention Description
Before, during and after surgery, bivalirudin was used according to the dosage regimen to assess it's impact on elderly patients with diabetes mellitus undergoing selective PCI.
Primary Outcome Measure Information:
Title
activated clotting time(ACT)
Description
The ACT test can be used to monitor anticoagulation effects, such as high-dose heparin before, during, and shortly after procedures that require intense anticoagulant administration, such as cardiac bypass, cardiac angioplasty, thrombolysis, extra-corporeal membrane oxygenation (ECMO) and continuous dialysis
Time Frame
5min after using drug
Secondary Outcome Measure Information:
Title
30-day major adverse cardiac events
Description
30-day major adverse cardiac events including recidivation of angina pectoris, in-stent restenosis, severe arrhythmia, cardiac failure, sudden cardiac death.
Time Frame
30 days
Title
30-day bleeding events
Description
According to the bleeding academic research consortium (BARC) bleeding classification.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥ 65 years, with diabetes mellitus.
Patients who undergo selective PCI therapy.
Patients who agree to participate in this clinical trial and sign informed consent prior to surgery.
Exclusion Criteria:
Patients with acute coronary syndrome undergoing primary PCI.
Combined with other diseases, the life expectancy of patients don't exceed 1 year.
Patients with active bleeding.
Bleeding in the gastrointestinal or urogenital tract in the past 6 weeks.
Combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc.
Patients who have undergone major surgery in the last 1 month.
A history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms.
Patients with cardiogenic shock, or suspected myocarditis, infective endocarditis.
Patients who received regular heparin therapy within 6 hours or low molecular weight heparin therapy within 8 hours, or other factors that the researchers believe may influence the outcome of the trial.
Patients with severe uncontrolled hypertension.
Patients with active hepatitis, HIV and other infectious diseases.
Patients with contraindications of bivalirudin and heparin.
Other researchers considered the patients are unfit to participate in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Gong, Master
Phone
15583407654
Email
1500113940@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qian Gong, Master
Organizational Affiliation
Mian Yang Central Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)
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