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Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients

TerminatedPhase 4

Sponsor: Spanish Society of Cardiology

Conditions: Acute Myocardial Infarction

Interventions: Tenecteplase + UFH (+ clopidogrel, since 01/97), Primary angioplasty

Countries: Spain

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 or LBBB AMI \<6 hours of evolution without contraindications for TT. Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT in patients \>=75 years old with AMI. Participating Centers: 27 Spanish hospitals performing \>50 PA/year. Primary Endpoint (PE): Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30 days. There are also 7 secondary endpoints (SE). Procedure: Diagnosis of inclusion/exclusion criteria --\> Centralized randomization --\> Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months. Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety Committee and Event Adjudication Committee formed by experts not participating in the study.

Eligibility overview

Sex: ALL

Age: 75 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

INCLUSION CRITERIA:

1. Subjects of 75 or more years of age
2. 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:

1. ST-elevation \>=2 mm in 2 or more precordial leads
2. ST-elevation \>=1 mm in 2 or more anterior leads
3. Complete de novo (or probably de novo) left bundle branch block (LBBB)
3. 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:

1. 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
2. Cardiogenic shock
3. Estimated door-to-needle time \>120 minutes
4. Administration of fibrinolysis in the 14 days prior to randomization
5. Administration of any glycoprotein IIa/IIIb inhibitor in the 24 hours prior to randomization
6. Administration of any Low Molecular Weight Heparin (LMWH) in the 8 hours prior to randomization
7. Actual oral anticoagulant treatment
8. 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)
9. Dementia or acute confusional state at the time of randomization
10. Subject incapacity or unwillingness to give informed consent -at least, verbally
11. Known renal failure (basal creatinine\> 2,5 mg/dl)
12. Reduced life expectancy (\<12 months) due to advanced or terminal concomitant condition
13. Subject participation in another clinical trial (assessing a drug or a device) in the 30 days prior to randomization

Locations (23)

Palma de Mallorca, Balearic Islands, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Santander, Cantabria, Spain
Granada, Granada, Spain
Huelva, Huelva, Spain
A Coruña, La Coruña, Spain
Santiago de Compostela, La Coruña, Spain
León, León, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Málaga, Spain
Pamplona, Navarre, Spain
Oviedo, Principality of Asturias, Spain
Seville, Sevilla, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Toledo, Toledo, Spain
Valencia, Valencia, Spain
Valladolid, Valladolid, Spain
Barakaldo, Vizcaya, Spain