Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03567408
• Other study ID #: 123456789
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 15, 2018
• Est. completion date: August 12, 2020

Study information

• Verified date: August 2018
• Source: Mianyang Central Hospital
• Contact: Qian Gong, Master
• Phone: 15583407654
• Email: 1500113940[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 12, 2020
• Est. primary completion date: August 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qian Gong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5min after using drug
Secondary	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 days
Secondary	30-day bleeding events	According to the bleeding academic research consortium (BARC) bleeding classification.	30 days