Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients (TRIANA)

This study has been terminated.
(Slow recruitment)
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Sanofi-Synthelabo
Cordis Corporation
Medtronic
Guidant Corporation
Boston Scientific Corporation
Information provided by:
Spanish Society of Cardiology
ClinicalTrials.gov Identifier:
NCT00257309
First received: November 18, 2005
Last updated: May 19, 2008
Last verified: May 2008
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97)
Procedure: Primary angioplasty
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Spanish Society of Cardiology:

Primary Outcome Measures:
  • Incidence of Death or Reinfarction or Disabling stroke [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 266
Study Start Date: April 2005
Estimated Study Completion Date: December 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TT
Weight adjusted TNK + UFH
Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97)
Active Comparator: PA
Primary angioplasty
Procedure: Primary angioplasty

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257309

Locations
Spain
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33006
Hospital Universitario Son Dureta
Palma de Mallorca, Baleares, Spain, 07003
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Complejo Hospitalario de León
Leon, León, Spain, 24010
Hospital Universitario "Virgen de la Victoria"
Malaga, Málaga, Spain, 29010
Hospital de Navarra
Pamplona, Navarra, Spain, 31008
Hospital Universitario de Canarias
La Laguna, Tenerife, Spain, 38320
Hospital de Cruces
Barakaldo, Vizcaya, Spain, 48903
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18012
Hospital Juan Ramón Jiménez
Huelva, Spain, 21005
Complejo Hospitalario Universitario "Juan Canalejo"
La Coruña, Spain, 15006
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital General Universitario "Gregorio Maranon"
Madrid, Spain, 28007
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Clínico "San Carlos"
Madrid, Spain, 28040
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Complejo Hospitalario de Toledo Hospital Virgen de la Salud
Toledo, Spain, 45004
Consorcio Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Clínico Universitario de Valladolid
Valladolid, Spain, 47005
Sponsors and Collaborators
Spanish Society of Cardiology
Fondo de Investigacion Sanitaria
Sanofi-Synthelabo
Cordis Corporation
Medtronic
Guidant Corporation
Boston Scientific Corporation
Investigators
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)
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT00257309     History of Changes
Other Study ID Numbers: EUDRACT 2004-001943-31, FIS PI042122
Study First Received: November 18, 2005
Last Updated: May 19, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Society of Cardiology:
Acute myocardial infarction
Elderly
Thrombolysis
Primary angioplasty
Randomized trial
Efficacy
Safety

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Clopidogrel
Tenecteplase
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014