Status:
COMPLETED
A Trial of Low-dose Adjunctive alTeplase During prIMary PCI
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Glasgow
National Institute for Health Research, United Kingdom
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety and efficacy of reduced doses (10 mg and 20 mg) of intra-coronary alteplase compared with placebo as an adjunct to PCI in reducing MVO and its cons...
Detailed Description
Despite numerous interventions, there remains a need to develop new ways to prevent microvascular obstruction (MVO). The investigators aim to select patients with persistent S-T-elevation on the ECG a...
Eligibility Criteria
Inclusion
- Males aged ≥ 18 years; females ≤ 18 years not of child bearing potential (defined as women who are post-menopausal or permanently sterilised (e.g. hysterectomy, tubal occlusion, bilateral salpingectomy)
- Acute myocardial infarction (symptoms onset ≤ 6 hours) with persistent ST-segment elevation or recent left bundle branch block
- Coronary artery occlusion (TIMI coronary flow grade 0 or 1) OR Impaired coronary flow (TIMI flow grade 2, slow but complete filling) in the presence of definite angiographic evidence of thrombus (TIMI grade 2+)
- Proximal-mid culprit lesion location in a major coronary artery (ie the right, left anterior descending, intermediate or circumflex coronary artery)
- Radial artery access
Exclusion
- Shock (systolic blood pressure \<90 mmHg with clinical signs of peripheral hypoperfusion despite adequate filling)
- Normal coronary flow grade (TIMI flow grade 3) at initial angiography
- Functional coronary collateral supply (Rentrop grade 2/3) to culprit artery
- Multivessel PCI intended before the day 2-7 MRI Scan
- Non-cardiac co-morbidity with expected survival \<1 year
- Estimated body weight \<60kg
- Contra-indication to contrast-enhanced MRI
- Pacemaker
- Implantable defibrillator
- estimated Glomerular Filtration Rate (eGFR) \<30ml/min/1.73m²
- previous infarction in the culprit artery (known or suspected clinically, e.g. wall motion abnormality revealed by echocardiography)
- Significant bleeding problem either at present or within the past 6 months
- Patients with current concomitant oral anticoagulant therapy (INR \> 1.3), including apixaban, dabigatran and rivaroxaban
- Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial, or spinal surgery)
- Known Haemorrhagic diathesis
- Severe uncontrolled hypertension \>180/110 mmHg not controlled by medical therapy
- Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current STEMI)
- Recent trauma to the head or cranium (\<2 months)
- Prolonged cardiopulmonary resuscitation (\>2 minutes) within past 2 weeks
- Acute pericarditis and/or subacute bacterial endocarditis e.g. valve mass or vegetation revealed by echocardiography
- Acute pancreatitis
- Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis
- Arterial aneurysm and known arterial/venous malformation
- Neoplasm with increased bleeding risk
- Any known history of haemorrhagic stroke or stroke of unknown origin
- Known history of ischaemic stroke or transient ischaemic attack \<6 months
- Dementia
- Hypersensitivity to gentamicin
- Women of child-bearing potential (i.e. pre-menopause) or breast feeding
- Previous randomisation to this study or participation in a study with an investigational drug or medical device within 90 days prior to randomisation
- Incapacity or inability to provide informed consent
- requirement for immunosuppressive drug therapy at any time during the past 3 months; whether administered orally, subcutaneously or intravenously. This would include corticosteroids (but not inhaled or topical), drugs used following transplantation (e.g. tacrolimus, cyclosporine), anti-metabolite therapies (e.g. mycophenolic acid (Myfortic), azathioprine, leflunomide (Arava)), and immunomodulators including biologics (e.g. adalimumab (HUMIRA), etanercept (Enbrel), aldesleukin), and DMARDS (cyclophosphamide. methotrexate, etc). Please note that this list is not exhaustive and a requirement for other immunosuppressive drugs not listed would also exclude the patient.
- active or prophylactic treatment with oral or parenteral antibiotic, antifungal or antiviral therapy to prevent or treat infection.
- any anti-cancer treatment (excluding surgery as this is covered above) at any time during the past 3 months including chemotherapy, radiotherapy and treatment with biologics such as Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitors (e.g. bevacizumab, pazopanib). This list is not exhaustive and the sponsor or CI should be contacted for advice if required.
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2019
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT02257294
Start Date
March 1 2016
End Date
May 8 2019
Last Update
September 6 2019
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Edinburgh Royal Infirmary
Edinburgh, United Kingdom
2
Golden Jubilee National Hospital
Glasgow, United Kingdom, G81 4HX
3
Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
4
Glenfield Hospital
Leicester, United Kingdom