Study Stopped
Slow recruitment
Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients
TRIANA
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
2 other identifiers
interventional
266
1 country
23
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2005
Longer than P75 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 18, 2005
CompletedFirst Posted
Study publicly available on registry
November 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
January 19, 2017
CompletedJanuary 19, 2017
November 1, 2016
2.8 years
November 18, 2005
October 2, 2016
November 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Death or Reinfarction or Disabling Stroke
Incidence of all-cause death or myocardial reinfarction or disabling stroke
30 days
Death/Reinfarction/Disabling Stroke at 30 Days
Incidence of Death or Reinfarction or Disabling Stroke at 30 days
30 days
Study Arms (2)
Thrombolysis
ACTIVE COMPARATORWeight adjusted tenecteplase bolus + Unfrationated heparin
Primary angioplasty
ACTIVE COMPARATORPrimary angioplasty
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Society of Cardiologylead
- Fondo de Investigacion Sanitariacollaborator
- Sanoficollaborator
- Cordis US Corp.collaborator
- Medtroniccollaborator
- Guidant Corporationcollaborator
- Boston Scientific Corporationcollaborator
Study Sites (23)
Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, 07003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Barcelona, 08036, Spain
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Virgen de las Nieves
Granada, Granada, 18012, Spain
Hospital Juan Ramón Jiménez
Huelva, Huelva, 21005, Spain
Complejo Hospitalario Universitario "Juan Canalejo"
A Coruña, La Coruña, 15006, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, 15706, Spain
Complejo Hospitalario de León
León, León, 24010, Spain
Hospital General Universitario "Gregorio Maranon"
Madrid, Madrid, 28007, Spain
Hospital Clínico "San Carlos"
Madrid, Madrid, 28040, Spain
Hospital 12 de Octubre
Madrid, Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, Madrid, 28046, Spain
Hospital Universitario "Virgen de la Victoria"
Málaga, Málaga, 29010, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33006, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41009, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Complejo Hospitalario de Toledo Hospital Virgen de la Salud
Toledo, Toledo, 45004, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Hospital Clínico Universitario de Valladolid
Valladolid, Valladolid, 47005, Spain
Hospital de Cruces
Barakaldo, Vizcaya, 48903, Spain
Related Publications (3)
Bardaji A, Bueno H, Fernandez-Ortiz A, Cequier A, Auge JM, Heras M. [Type of treatment and short-term outcome in elderly patients with acute myocardial infarction admitted to hospitals with a primary coronary angioplasty facility. The TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) Registry]. Rev Esp Cardiol. 2005 Apr;58(4):351-8. Spanish.
PMID: 15847731BACKGROUNDCequier A, Bueno H, Auge JM, Bardaji A, Fernandez-Ortiz A, Heras M. [Characteristics and mortality following primary percutaneous coronary intervention for acute myocardial infarction in Spain. Results from the TRIANA 1 (TRatamiento del Infarto Agudo de miocardio eN Ancianos) Registry]. Rev Esp Cardiol. 2005 Apr;58(4):341-50. Spanish.
PMID: 15847730BACKGROUNDBueno H, Betriu A, Heras M, Alonso JJ, Cequier A, Garcia EJ, Lopez-Sendon JL, Macaya C, Hernandez-Antolin R; TRIANA Investigators. Primary angioplasty vs. fibrinolysis in very old patients with acute myocardial infarction: TRIANA (TRatamiento del Infarto Agudo de miocardio eN Ancianos) randomized trial and pooled analysis with previous studies. Eur Heart J. 2011 Jan;32(1):51-60. doi: 10.1093/eurheartj/ehq375. Epub 2010 Oct 22.
PMID: 20971744RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Héctor Bueno
- Organization
- Centro Nacional de Investigaciones Cardiovasculares
Study Officials
- 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)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- (Past) President. WG on IHD
Study Record Dates
First Submitted
November 18, 2005
First Posted
November 22, 2005
Study Start
April 1, 2005
Primary Completion
February 1, 2008
Study Completion
December 1, 2008
Last Updated
January 19, 2017
Results First Posted
January 19, 2017
Record last verified: 2016-11