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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03567408
Other study ID # 123456789
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


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
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