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TENECTEPLASE IN PROSTHETIC HEART VALVE THROMBOSIS

TENECTEPLASE VS ALTEPLASE IN PHVT: A PILOT RANDOMIZED TRIAL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046127
Enrollment
100
Registered
2022-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: I39- Endocarditis and heart valve disorders in diseases classified elsewhere

Interventions

Intervention1: TENECTEPLASE: Weight based bolus will be given, similar to the bolus regimen of Tenecteplase used in Myocardial Infarction. Maximum of 2 doses will be given to the patient, if necessary

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All obstructive PHVT patients presenting to emergency or Cardiology OPD 2. Patients willing to give written informed consent

Exclusion criteria

Exclusion criteria: 1. Contra-indications to thrombolytic therapy 2. Obstructive Pannus, Non obstructive PVT 3. Prosthetic valve endocarditis 4. Pregnancy 5. Age 6. Malignancy 7. End stage liver disease 8. Pts in Cardiogenic shock 9. Patients not willing to give written informed consent

Design outcomes

Primary

MeasureTime frame
•Primary efficacy outcome: To determine the complete success rate in PHVT patients treated with alteplase and Tenecteplase. •Primary safety outcome: To determine the mortality, and incidence of major complications like ischemic/hemorrhagic stroke, peripheral embolism and major bleeding .requiring transfusion in PHVT patients treated with TNK or Alteplase. Timepoint: One Time Post Intervention

Secondary

MeasureTime frame
• Secondary efficacy outcomes – To determine the partial success rate in patients undergoing thrombolysis with Alteplase or Tenecteplase for PHVT and duration of hospital stay. • Secondary safety outcomes – To determine incidence of minor complicatons like bleeding without requirement for transfusion, and TIA in PHVT patients treated with TNK or Alteplase. Timepoint: One Time Post Intervention

Countries

India

Contacts

Public ContactAkkineni Krishna Prasad

AIIMS New Delhi

drsharmagautam@gmail.com9811388311

Outcome results

None listed

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