Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Procedure: Selective PCI; Drug: Bivalirudin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qian Gong, Master; Phone Number: 15583407654; Email: 1500113940@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Selective PCI with bivalirudin; 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.	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.; Other Names: Angiomax
Placebo Comparator: Unfractionated heparin; 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.	Procedure: Selective PCI; Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
30-day bleeding events	According to the bleeding academic research consortium (BARC) bleeding classification.	30 days

Collaborators and Investigators

• Sponsor: Qian Gong
• Investigators: Study Chair: Qian Gong, Master, Mian Yang Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2018
• Primary Completion (Anticipated): August 12, 2019
• Study Completion (Anticipated): August 12, 2020

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 25, 2018

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Bivalirudin
• Other Study ID Numbers: 123456789

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No