Comparing the safety and efficacy of Altelyse with Actilyse in acute myocardial infarctio

Phase 3

Recruiting

• Conditions: Acute Myocardial Infarction with ST elevation.; ST elevation (STEMI) myocardial infarction of unspecified site; I21.3

• Registration Number: IRCT20190729044366N1
• Lead Sponsor: Arena Life Science Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Chest pain compatible with ischemic heart disease for more than 20 minutes
Start of symptoms of Acute Myocardial Infarction (Peak of chest pain) 12 hours (Maximum) before thrombolytic treatment
Signs of Acute Myocardial Infarction in Electrocardiogram: ST elevation of 0.1 mili-volt or more in two adjacent leads other than v2 and v3; ST elevation of 0.25 mili-volt or more in v2 and v3 leads in men younger than 40 years; ST elevation of 0.2 mili-volt or more in v2 and v3 leads in men older than 40 years; ST elevation of 0.15 mili-volt or more in v2 and v3 leads in women irrespective of their age.
Lack of access to cath lab to do PPI, Primary Per-cutaneous Coronary Intervention or expecting a delay more than 2 hours between between first medical contact and performance of first balloon dilatation excluding the time takes from first medical contact till the start of thrombolytic therapy.
Signed informed consent
Age of 18 years or more

Exclusion Criteria

Presence of left bundle block in electrocardiogram
Presence of accompanying severe diseases such as renal failure (GFR<30); hepatic failure; POrtal hypertension; Hepatitis; Thrombocytopaenia; Known pancreatitis (information gathered from first clinical examination upon arrival because of cheat pain
Cardiogenic shock (Systolic pressure less than 90 mm Hg)
Killip class III & IV
Any history of intracranial bleeding or stroke with unknown origin irrespective of the time of occurrence
Ischemic stroke
Known central nervous system lesions, neoplasms (primary or metastatic), arteriovenous malformations
Aortic dissection
Active bleeding or known bleeding disorder (excluding menses)
Major trauma to Head and Neck in the last 3 months
Intracranial or spinal surgery in the last 2 months
Other major trauma or surgery within the preceding month
Gastrointestinal bleeding within the preceding month
Sever uncontrolled hypertension (Resistant to emergency treatment)
Non-compressible punctures in the past 24 hours (e.g. liver biopsy, lumbar puncture)
History of poorly controlled chronic hypertension
Hypertension at the time of eligibility assessment: Systolic BP >180 mm Hg or diastolic BP > 110 mm Hg
Transient ischemic attack in the preceding 6 months
Dementia
Pregnancy or within 1 week postpartum
Internal bleeding within the last 2-4 weeks
Active peptic ulcer
Infectious endocarditis
Cardiopulmonary resuscitation that has caused injury to the chest or lasted more than 10 minutes
Patients who receive anticoagulant therapy such as warfarin
Advanced liver disease
Known intracranial lesions other than those listed as absolute contraindications for thrombolytic therapy
Diabetic Hemorrhagic Retinopathy or other hemorrhagic ophthalmic conditions

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of ST resolution (STR) at 90 minutes. Timepoint: 90 minutes after start of thrombolytic therapy. Method of measurement: To estimate percentage of ST resolution at 90 minutes, we will measure the height of ST elevation at 20 milisecond after J point in those leads that have shown elevation of ST in a 12 lead standard ECG at time points 0 and 90. Sum of ST elevations in all 12 leads at 90 minutes will be deducted from the sum of ST elevations at time 0 to work out the total ST resolution (STR) at 90 minutes. We will then calculate the percentage of ST resolution by dividing total STR at 90 minutes to the sum of ST elevations at time 0. In a second measurement approach, percentage of patients who have had more than 50% resolution in their ECG lead with highest ST elevation will be calculated.