NCT03567408

Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Safety and Efficacy of Bivalirudin in Patients With Diabetes Mellitus Undergoing Percutaneous Coronary Intervention (PCI)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Qian Gong · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Selective PCI	Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus.
DRUG	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.

Timeline

• Start date: 2018-09-15
• Primary completion: 2019-08-12
• Completion: 2020-08-12
• First posted: 2018-06-25
• Last updated: 2018-08-20