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Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Primary Purpose

Coronary Heart Disease

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Selective PCI

Bivalirudin

About this trial

This is an interventional treatment trial for Coronary Heart Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

≥ 65 years, with diabetes mellitus.
Patients who undergo selective PCI therapy.
Patients who agree to participate in this clinical trial and sign informed consent prior to surgery.

Exclusion Criteria:

Patients with acute coronary syndrome undergoing primary PCI.
Combined with other diseases, the life expectancy of patients don't exceed 1 year.
Patients with active bleeding.
Bleeding in the gastrointestinal or urogenital tract in the past 6 weeks.
Combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc.
Patients who have undergone major surgery in the last 1 month.
A history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms.
Patients with cardiogenic shock, or suspected myocarditis, infective endocarditis.
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.
Patients with severe uncontrolled hypertension.
Patients with active hepatitis, HIV and other infectious diseases.
Patients with contraindications of bivalirudin and heparin.
Other researchers considered the patients are unfit to participate in this study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Selective PCI with bivalirudin

Unfractionated heparin

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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-day bleeding events

According to the bleeding academic research consortium (BARC) bleeding classification.

Full Information

NCT ID

NCT03567408

First Posted

June 1, 2018

Last Updated

August 16, 2018

Sponsor

Qian Gong

1. Study Identification

Unique Protocol Identification Number

NCT03567408

Brief Title

Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2018 (Anticipated)

Primary Completion Date

August 12, 2019 (Anticipated)

Study Completion Date

August 12, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Qian Gong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Selective PCI with bivalirudin

Arm Type

Experimental

Arm Description

Arm Title

Unfractionated heparin

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Selective PCI

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bivalirudin

Other Intervention Name(s)

Angiomax

Intervention Description

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.

Primary Outcome Measure Information:

Title

activated clotting time(ACT)

Description

Time Frame

5min after using drug

Secondary Outcome Measure Information:

Title

30-day major adverse cardiac events

Description

30-day major adverse cardiac events including recidivation of angina pectoris, in-stent restenosis, severe arrhythmia, cardiac failure, sudden cardiac death.

Time Frame

30 days

Title

30-day bleeding events

Description

According to the bleeding academic research consortium (BARC) bleeding classification.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥ 65 years, with diabetes mellitus. Patients who undergo selective PCI therapy. Patients who agree to participate in this clinical trial and sign informed consent prior to surgery. Exclusion Criteria: Patients with acute coronary syndrome undergoing primary PCI. Combined with other diseases, the life expectancy of patients don't exceed 1 year. Patients with active bleeding. Bleeding in the gastrointestinal or urogenital tract in the past 6 weeks. Combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc. Patients who have undergone major surgery in the last 1 month. A history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms. Patients with cardiogenic shock, or suspected myocarditis, infective endocarditis. 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. Patients with severe uncontrolled hypertension. Patients with active hepatitis, HIV and other infectious diseases. Patients with contraindications of bivalirudin and heparin. Other researchers considered the patients are unfit to participate in this study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qian Gong, Master

Phone

15583407654

1500113940@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qian Gong, Master

Organizational Affiliation

Mian Yang Central Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

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