Current partner codePEPTIDESDE
NCT03567408·Phase 2·INTERVENTIONAL

Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Status

Unknown

Phase

Phase 2

Enrollment

200

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jun 25, 2018

  2. Study start

    Sep 15, 2018

  3. Primary completion

    Aug 12, 2019

  4. Study completion

    Aug 12, 2020

  5. Results posted

    Not reported

  6. Registry updated

    Aug 20, 2018

Outcomes

What the study measures.

Primary outcomes

activated clotting time(ACT)

Time frame · 5min after using drug

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 outcomes

30-day major adverse cardiac events

Time frame · 30 days

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

Time frame · 30 days

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

Eligibility

Who can take part.

Minimum age
65 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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 locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.