A Multicentric (Max healthcare Hospital) Prospective Observational Investigator Initiated study to evaluate safety, efficacy and cost of effectiveness using Bivalirudin with provisional use of GP IIb/IIIa.

A Multicentric (Max Healthcare Hospital) Prospective Obsevational Investigator Initiated study to evaluate safety, efficacy and cost of effectiveness using Bivalirudin with provosinal use of GP IIb/IIIa inhibitors in a real world patient population undergoing percutaneous coronary intervention(PCI)in Max Hospitals. - CLIMAX

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2012/12/003260

Enrollment

1000

Registered

2012-12-26

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

Health Condition 1: null- Coronary heart Disease

Interventions

Intervention1: Bivalirudin: 0.75 mg/kg IV bolus + 1.75 mg/kg/h infusion (duration of procedure) â?¢ACT after 5 minutes of administering the bolus dose. Additional bolus of 0.3 mg/kg if needed (if ACT2

Eligibility

Inclusion criteria

Inclusion criteria: Patients should be included if ALL of the following criteria are met: • Age: 18 years or older • Patient who can provide written informed consent for collection of data as approved by the ethics committee • Patients undergoing PCI

Exclusion criteria

Exclusion criteria: Patients should be excluded if ANY of the following criteria is met: • Patients who cannot provide informed consent for collection of data • Allergy to bivalirudin or Aspirin, or known sensitivity to any component of the products • Noncardiac coexisting conditions that could limit life expectancy to less than 1 year • Known pregnancy or nursing mothers. Women of child-bearing age will be screened for pregnancy and will have to adopt birth control measures till the duration of the study. • Treatment with Low Molecular Weight Heparin (LMWH) within 8 hours prior to the intervention • Warfarin MUST be discontinued prior to procedure, and the INR>=1.5, or the PT15 • Dabigatran MUST be discontinued 1 to 2 days (CrCl >=50 mL/min) or 3 to 5 days (CrCl 50 mL/min) prior to procedure

Design outcomes

Primary

Measure	Time frame
- Incidence of major bleedng at hospital discharge. -Evaluation of net adverse Clinical events(NACE). -Evaluation of cost of therapy. Timepoint: - Incidence of major bleedng at hospital discharge. -Evaluation of net adverse Clinical events(NACE). -Evaluation of cost of therapy.	—

Secondary

Measure	Time frame
â?¢ To evaluate incidence of minor bleeding â?¢ To evaluate cost effectiveness of bivalirudin as compared to combined use of Heparin and GP IIb/ IIIa inhibitors from historical data. Timepoint: â?¢ To evaluate incidence of minor bleeding â?¢ To evaluate cost effectiveness of bivalirudin as compared to combined use of Heparin and GP IIb/ IIIa inhibitors from historical data.	—

Countries

India

Contacts

Public ContactDr Viveka Kumar

Max super speciality hospital

viveka.kumar@maxhealthcare.com09871001190

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026