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Status:

TERMINATED

Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients

Lead Sponsor:

Spanish Society of Cardiology

Collaborating Sponsors:

Fondo de Investigacion Sanitaria

Sanofi

Conditions:

Acute Myocardial Infarction

Eligibility:

All Genders

75+ years

Phase:

PHASE4

Brief Summary

General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of thrombolytic therapy (TT) for the treatment of AMI in patients \>=75 years old with ST-segment elevation o...

Detailed Description

Hypothesis of the study. In patients of 75 or more years of age with AMI and ST-elevation or LBBB, the treatment strategy based on primary angioplasty is superior to the treatment strategy based on in...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Subjects of 75 or more years of age
  • Diagnosis of AMI: chest pain or any symptom of myocardial ischemia of, at least, 20 minutes of duration, not responding to nitrate therapy, an evolution period of less than 6 hours after symptom onset until randomization process, and, at least, one of the following alterations:
  • ST-elevation \>=2 mm in 2 or more precordial leads
  • ST-elevation \>=1 mm in 2 or more anterior leads
  • Complete de novo (or probably de novo) left bundle branch block (LBBB)
  • Subject should be able to give informed consent prior to randomization process and should agree to fulfill all procedures described in the protocol, including follow-up after hospital discharge. A written consent signed by a close relative with witness is also acceptable.
  • EXCLUSION CRITERIA:
  • Documented contraindication to the use of fibrinolytics. 1.1. Internal active bleeding or known history of hemorrhagic diathesis 1.2. History of previous CVA of any kind or at any time 1.3. Intracranial tumor, arteriovenous malformation, aneurysm or cerebral aneurysm repair 1.4. Major surgery, parenchymal biopsy, ocular surgery or severe traumatism in the 6 weeks prior to randomization 1.5. Unexplained puncture in a non-compressible vascular location in the last 24 hours prior to randomization 1.6. Confirmed arterial hypertension with a reliable measurement of systolic AP \>180 mmHg or diastolic AP \>110 mmHg 1.7. Known thrombocytopenia \< 100.000 platelets/mL 1.8. Prolonged (\>20 minutes) or traumatic cardiopulmonar resuscitation (CPR) in the 2 weeks prior to randomization 1.9. History or signs suggesting aortic dissection
  • Cardiogenic shock
  • Estimated door-to-needle time \>120 minutes
  • Administration of fibrinolysis in the 14 days prior to randomization
  • Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hours prior to randomization
  • Administration of any Low Molecular Weight Heparin (LMWH) in the 8 hours prior to randomization
  • Actual oral anticoagulant treatment
  • Suspected AMI secondary to occlusion of one lesion treated previously with a percutaneous coronary intervention (within the previous 30 days for angioplasty or conventional stent and within the previous 12 months for coated stents)
  • Dementia or acute confusional state at the time of randomization
  • Subject incapacity or unwillingness to give informed consent -at least, verbally
  • Known renal failure (basal creatinine\> 2,5 mg/dl)
  • Reduced life expectancy (\<12 months) due to advanced or terminal concomitant condition
  • Subject participation in another clinical trial (assessing a drug or a device) in the 30 days prior to randomization

Exclusion

    Key Trial Info

    Start Date :

    April 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2008

    Estimated Enrollment :

    266 Patients enrolled

    Trial Details

    Trial ID

    NCT00257309

    Start Date

    April 1 2005

    End Date

    December 1 2008

    Last Update

    January 19 2017

    Active Locations (23)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (23 locations)

    1

    Hospital Universitario Son Dureta

    Palma de Mallorca, Balearic Islands, Spain, 07003

    2

    Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, Spain, 08025

    3

    Hospital Clinic i Provincial de Barcelona

    Barcelona, Barcelona, Spain, 08036

    4

    Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, Spain, 08907