A Study of Pre-hospital Treatment of Acute Myocardial Infarction Based on Diagnosis by Interpretation of Remotely Acquired ECG and Thrombolysis With Accelerated Alteplase ( Actilyse®) (PHARAOH)

Boehringer Ingelheim

Status: Terminated

Conditions: Myocardial Infarction

Treatments: Drug: Alteplase (Actilyse); Drug: Standard therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT02235389

135.301

Details and patient eligibility

About

The general aim of this study was to assess the feasibility of treating acute myocardial infarction (AMI) by physician-directed pre-hospital thrombosis, using accelerated alteplase (Actilyse®) and a diagnostic technique involving remote electrocardiogram (ECG) acquisition by paramedics

Enrollment: 59 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ischemic cardiac pain of >= 20 minutes and <= 6 hours
• Age 18 - 80 years
• Ability to give informed consent (witnessed verbal or written)
• Ability to follow protocol and comply with follow -up requirements

Exclusion criteria

• Current participation in another clinical trial

• Patient will be ineligible for pre hospital administration of actilyse if any of the following apply:

  • Acute myocardial infarction (AMI) treated with a thrombolytic agent within the preceding 4 days
  • BP (blood pressure) > 180/100 mmHg (on one measurement)
  • Significant bleeding disorder within the past 6 months
  • Major surgery, biopsy of a parenchymal organ, or significant trauma (including any trauma associated with the current AMI) within 3 months
  • History of stroke, transient ischaemic attack, or central nervous system structural damage (e.g. neoplasm, aneurysm, intracranial surgery)
  • Oral anticoagulation
  • Recent (within 10 days) non - compressible vascular puncture
  • Pregnancy (positive urine pregnancy test) or lactation, parturition within the previous 30 days, or female of childbearing potential not using adequate birth control (oral contraception)
  • Severe liver disease, including hepatic failure, cirrhosis portal hypertension (oesophageal varices) and active hepatitis
  • Diabetes with definite history of retinopathy
  • Other serious illness (e.g. malignancy, active infection)
  • Bacterial endocarditis / pericarditis
  • Acute pancreatitis
  • Documented ulcerative gastrointestinal disease during last 3 month, arterial aneurysms, arterial / venous malformations
  • Any other condition that the investigator feels would pose a significant hazard to the subject if the investigational therapy was to be initiated

• Patients who are not excluded from thrombolytic therapy by the criteria above will, in addition, need to satisfy the following 'inclusion' criteria prior to the pre - hospital thrombolysis:

  • 12 lead ECG criteria: ST segment elevation >= 0.1 mV in two contiguous electrocardiogram (ECG) standard leads indicative of AMI, or ST elevation >= 0.2 mV in two contiguous chest leads and all left bundle branch block (LBBB) with clinical indication of AMI

Trial design

59 participants in 2 patient groups

Administration of thrombolytic treatment with PHARAOH

Description:

Pre-Hospital Alteplase Remote Advice of Hospital (PHARAOH)

Treatment:

Drug: Alteplase (Actilyse)

Standard therapy with thrombolytic treatment in Hospital

Treatment:

Drug: Standard therapy