Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

NCT ID: NCT03567408

Last Updated: 2018-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2020-08-12

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Selective PCI with bivalirudin

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.

Group Type: EXPERIMENTAL

Selective PCI

Intervention Type: PROCEDURE

Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus.

Bivalirudin

Intervention Type: DRUG

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.

Unfractionated heparin

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.

Group Type: PLACEBO_COMPARATOR

Selective PCI

Intervention Type: PROCEDURE

Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus.

Interventions

Selective PCI

Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus.

Intervention Type: PROCEDURE

Bivalirudin

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.

Intervention Type: DRUG

Other Intervention Names

Angiomax

Eligibility Criteria

Inclusion Criteria

1. ≥ 65 years, with diabetes mellitus.

2. Patients who undergo selective PCI therapy.

3. Patients who agree to participate in this clinical trial and sign informed consent prior to surgery.

Exclusion Criteria

1. Patients with acute coronary syndrome undergoing primary PCI.

2. Combined with other diseases, the life expectancy of patients don't exceed 1 year.

3. Patients with active bleeding.

4. Bleeding in the gastrointestinal or urogenital tract in the past 6 weeks.

5. Combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc.

6. Patients who have undergone major surgery in the last 1 month.

7. A history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms.

8. Patients with cardiogenic shock, or suspected myocarditis, infective endocarditis.

9. 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.

10. Patients with severe uncontrolled hypertension.

11. Patients with active hepatitis, HIV and other infectious diseases.

12. Patients with contraindications of bivalirudin and heparin.

13. Other researchers considered the patients are unfit to participate in this study.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qian Gong

OTHER

Sponsor Role: lead

Responsible Party

Qian Gong

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Qian Gong, Master

Role: STUDY_CHAIR

Mian Yang Central Hospital

Central Contacts

Qian Gong, Master

Role: CONTACT

1500113940@qq.com

15583407654

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id