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Clinical trial of Intracoronary Thrombolysis with Tenecteplase in premature age patients (under 40yrs) with Heart attack.

Primary Percutaneous Intracoronary Thrombolysis - Tenecteplase : A pilot study - P-PIT Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016213
Enrollment
100
Registered
2018-10-30
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: I219- Acute myocardial infarction, unspecified

Interventions

Intervention1: Primary Percutaneous Intracoronary Thrombolysis with Tenecteplase: PATIENTS WITH ST ELEVATION MYOCARDIAL INFARCTION WILL BE TREATED WITH PERCUTANEOUS INTRACORONARY THROMBOLYSIS WITH TEN

Sponsors

DR C N MANJUNATH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (a) Men aged 40 years old or younger (b) Women aged 40 years old or younger (c) Presentation to hospital (d) All patients with diagnosis of STEMI, as evidenced by: • Detection of a rise and/or fall in cardiac biomarker value (Trop-T), with at least one value above the 99th percentile of the upper reference range and with at least one of the following: - Symptoms of ischemia - New or presumed new significant ST-segment T wave (ST-T) changes or new LBBB - Development of pathologic Q waves on the ECG - Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality - Identification of an intracoronary thrombus by angiography

Exclusion criteria

Exclusion criteria: (a) Patients with previous history of ischemic heart disease/ PTCA / CABG. (b) Patients with history of cardiomyopathy (c) Patients with mechanical complications of STEMI (d) Resuscitated Cardiac Arrest, severe LV dysfunction, Kilip-III and IV on presentation to hospital. (e) Patients with unstable haemodynamics (f) Patients with absolute contraindications for the use of fibrinolytic agents: -Any previous intracranial haemorrhage -Known structural cerebral vascular lesion (e.g., arteriovenous malformation) -Known malignant intracranial neoplasm (primary or metastatic) -Ischemic stroke within 3 months except acute ischemic stroke within 4.5 hours -Suspected aortic dissection -Active bleeding or bleeding diathesis (excluding menses) -Significant closed-head or facial trauma within 3 months -Intracranial or intraspinal surgery within 2 months -Severe uncontrolled hypertension (unresponsive to emergency therapy) (g) Patients having a history of diabetes mellitus, chronic alcoholism, concomitant liver, kidney disease, cerebrovascular disease and acute / chronic infection (e) Patients unwilling to give informed consent

Design outcomes

Secondary

MeasureTime frame
(1) Functional class (NYHA class) (2) Assessment of left ventricular (LV) function - Ejection fraction (EF) - Global longitudinal strain of LV (3) Non-invasive assessment by TMT. Timepoint: 1 year

Primary

MeasureTime frame
(1) Assessment of Reperfusion - TIMI Flow Grade - ST Segment resolution on ECG - Angina relief as per the chest pain scale (2) In hospital mortality (3) Stroke / major bleeding (4) MACEs (Any death, repeat nonfatal myocardial infarction (MI) and infarct related artery (IRA) revascularization).. Timepoint: 1 year

Countries

India

Contacts

Public ContactRANI B J

SRI. JAYADEVA INSTITUTE OF CARDIOVASCULAR SCIENCES AND RESEARCH

drlaxmihsn@gmail.com9481439880

Outcome results

None listed

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