Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

• Status: Unknown status
• Trial end date: 2020-08-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qian Gong
• Treatments: Bivalirudin; Calcium heparin; Heparin; Hirudins

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.