A comparative clinical trial to understand efficacy and safety of R-TPR-012/ Metalyse® in Patients with heart attack

Phase 3

Active, not recruiting

• Conditions: Patients with ST segment elevation Myocardial Infarction

• Registration Number: CTRI/2016/09/007230
• Lead Sponsor: Reliance Life sciences Pvt Ltd

Brief Summary

This is a prospective, multi-centre, open-label, two-arm, parallel group, active-control, randomized comparative clinical study.

STEMI

The study is

to determine whether R-TPR-012 (Tenecteplase) is comparable to Metalyse® in efficacy as determined by TIMI (Thrombolysis In Myocardial Infarction) perfusion grades  and all-cause mortality rate at 30 days post dosing in subjects with STEMI following treatment with R-TPR-012/Metalyse®.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-09
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Male and female subjects in the range of 18 to 65 years of age (inclusive).
• Subjects presenting with chest pain and/or equivalent symptoms and diagnosis of Acute Myocardial Infarction confirmed by physician along with following ECG changes (12 lead).
• ï‚· ST elevation of ≥ 0.1 mV in two or more limb leads or ï‚· ST elevation of ≥ 0.2 mV in two or more contiguous precordial leads 3.
• Subjects presenting with AMI within 6 hours of occurrence of symptoms.
• Women of child bearing potential having a negative pregnancy test and taking adequate birth control measures.
• Consent from Legally Acceptable Representative (LAR), if subject is not in the condition to give consent.
• However, when the subject is stable and is able to give consent, consent would be obtained to confirm his/her willingness to continue in the study 6.
• Subjects must be able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

• Subjects with Left Bundle Branch Block (LBBB).
• History of contraindication to the use of thrombolytics.
• Internal active bleeding or known history of hemorrhagic diathesis.
• Any known history of haemorrhagic stroke or stroke of unknown origin 5.
• Any history of ischaemic stroke or transient ischaemic attack in the preceding 6 months 6.
• History of intracranial tumor, arteriovenous malformation, cerebral aneurysm, major surgery, parenchymal biopsy, ocular surgery and/or significant trauma within the past 2 months (this includes any trauma associated with the current AMI).
• Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to screening for study.
• Confirmed arterial hypertension of systolic BP 200 mm Hg and diastolic BP 110 mm Hg at entry which does not respond rapidly to treatment.
• Cardiogenic shock (Systolic BP 60 mm Hg) 10.
• Administration of Tenecteplase in the last 14 days prior to screening for study.
• Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hrs prior to screening for study.
• Subjects on oral anticoagulant treatment.
• Suspected AMI secondary to occlusion of one lesion treated previously with a per-cutaneous coronary intervention.
• Suspicion of aortic dissection.
• Subjects with subacute bacterial endocarditis and clinical pericarditis including pericarditis after this episode of acute myocardial Infarction.
• Pregnant and lactating females.
• Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis (based on history and examination) 18.
• Any other condition like active peptic ulceration, acute pancreatitis, which investigator feels would pose a significant hazard to subject if IP is administered 19.
• Participation in any clinical study of an investigational product within the previous 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint will be rate of TIMI 3 flow (Thrombolysis In Myocardial Infarction) of the infarct related artery at 90 minutes and all-cause mortality rate at 30 days post dosing in subjects with STEMI following treatment with R-TPR-012/Metalyse	30 DAYS

Secondary Outcome Measures

Name	Time	Method
1. 50% resolution of elevated ST segment	2. Events of myocardial re-infarction(s)

Trial Locations

Locations (14)

Arneja Heart and Multispeciality Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Chopda Medicare & Research Centre Pvt Ltd; 🇮🇳 Nashik, MAHARASHTRA, India

Dr. K Sambasivam; 🇮🇳 Coimbatore, TAMIL NADU, India

Dr. Sethuraman Selvamani; 🇮🇳 Madurai, TAMIL NADU, India

Dr.Ashok Bhupali; 🇮🇳 Kolhapur, MAHARASHTRA, India

Dr.Hemant Kokane; 🇮🇳 Pune, MAHARASHTRA, India

Dr.Rony Mathew; 🇮🇳 Ernakulam, KERALA, India

Dr.Sachin Patil; 🇮🇳 Kolhapur, MAHARASHTRA, India

G.V. Meditech Private Limited; 🇮🇳 Varanasi, UTTAR PRADESH, India

Meditrina Institute of Medical Sciences; 🇮🇳 Nagpur, MAHARASHTRA, India

Scroll for more (4 remaining)

Arneja Heart and Multispeciality Hospital

🇮🇳Nagpur, MAHARASHTRA, India

Dr Arneja Jaspal Singh

Principal investigator

7122450539

jaspalarneja_200@yahoo.com