NCT03567408

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 15, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2020

Completed
Last Updated

August 20, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

June 1, 2018

Last Update Submit

August 16, 2018

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 30-day major adverse cardiac events

    30 days

  • 30-day bleeding events

    30 days

Study Arms (2)

Selective PCI with bivalirudin

EXPERIMENTAL

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 PCIDrug: Bivalirudin

Unfractionated heparin

PLACEBO COMPARATOR

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

Interventions

Selective PCIPROCEDURE

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

Selective PCI with bivalirudinUnfractionated heparin
BivalirudinDRUG

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.

Also known as: Angiomax
Selective PCI with bivalirudin

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Disease

Interventions

bivalirudin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Qian Gong, Master

    Mian Yang Central Hospital

    STUDY CHAIR

Central Study Contacts

Qian Gong, Master

CONTACT

155834076541500113940@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2018

First Posted

June 25, 2018

Study Start

September 15, 2018

Primary Completion

August 12, 2019

Study Completion

August 12, 2020

Last Updated

August 20, 2018

Record last verified: 2018-08