Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients (TRIANA)
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|ClinicalTrials.gov Identifier: NCT00257309|
Recruitment Status : Terminated (Slow recruitment)
First Posted : November 22, 2005
Results First Posted : January 19, 2017
Last Update Posted : January 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myocardial Infarction||Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97) Procedure: Primary angioplasty||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||TRIANA: A Randomized Trial to Compare the Efficay and Safety of Thrombolysis With Primary Angioplasty as Initial Reperfusion Therapy in Older Patients (>= 75 Years Old) With Acute Myocardial Infarction|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||December 2008|
Active Comparator: Thrombolysis
Weight adjusted tenecteplase bolus + Unfrationated heparin
Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97)
Active Comparator: Primary angioplasty
Procedure: Primary angioplasty
- Incidence of Death or Reinfarction or Disabling Stroke [ Time Frame: 30 days ]Incidence of all-cause death or myocardial reinfarction or disabling stroke
- Death/Reinfarction/Disabling Stroke at 30 Days [ Time Frame: 30 days ]Incidence of Death or Reinfarction or Disabling Stroke at 30 days
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257309
|Principal Investigator:||Hector Bueno, MD, PhD||Spanish Society of Cardiology (WG on Ischemic Heart Disease and CCUs)|
|Principal Investigator:||Rosa Ana Hernández-Antolín, MD||Spanish Society of Cardiology (WG on Interventional Cardiology)|