A clinical trial to study the efficiency of a drug, Bivalrudin, in maintaining patency of effected coronary artery and heart muscle blood supply with acute heart pain patients.

Efficiency of Bivalrudin in maintaining patency of culprit coronary artery and myocardial perfusion in acute coronary syndrome patients.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000505

Enrollment

150

Registered

2010-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Bivalrudin: 0.1mg/Kg Intravenous Followed By 0.25mg/Kg/Hour Infusion For 24 Hours or 1.4ml bolus followed by 3.5ml/hr infusion over 12 hours Control Intervention1: unfractinated heparin

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged between 18 to 80 yrs with a diagnosis of acute coronary syndrome (unstable angina, Non Q MI), Unstable angina defined according to Bruwnwarld's classification, Non Q MI defined as classical chest pain for >20 minutes, with ST-T changes , not acute elevation on ECG and elevation of cardiac enzymes (out of three, two features are mandatory )

Exclusion criteria

Exclusion criteria: 1. Patients with thrombocytopenia or any other hematological abnormality. 2. Patient in cardiogenic shock. 3. Patients who refuses for bivalrudin treatment.

Design outcomes

Primary

Measure	Time frame
patency of culprit vessel represented by TIMI flows and myocardial perfusion by myocardial blush scoreTimepoint: cardiac catheterization 24 hours after bivalrudin or heparin infusion	—

Secondary

Measure	Time frame
All Cause Death, all types of different Bleeds, Allergic ReactionsTimepoint: at day 5 and day 30	—

Countries

India

Contacts

Public ContactRNV Narendra Kumar

Nizam'sInstitute of Medical Sciences(NIMS)

aditya.ms11@gmail.com040-23300483

Outcome results