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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborators:
Fondo de Investigacion Sanitaria
Sanofi
Cordis Corporation
Medtronic
Guidant Corporation
Boston Scientific Corporation
Information provided by (Responsible Party):
Héctor Bueno, Spanish Society of Cardiology

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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2005
Actual Primary Completion Date : February 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Thrombolysis
Weight adjusted tenecteplase bolus + Unfrationated heparin
Drug: Tenecteplase + UFH (+ clopidogrel, since 01/97)
Active Comparator: Primary angioplasty
Primary angioplasty
Procedure: Primary angioplasty



Primary Outcome Measures :
  1. Incidence of Death or Reinfarction or Disabling Stroke [ Time Frame: 30 days ]
    Incidence of all-cause death or myocardial reinfarction or disabling stroke

  2. Death/Reinfarction/Disabling Stroke at 30 Days [ Time Frame: 30 days ]
    Incidence of Death or Reinfarction or Disabling Stroke at 30 days



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


Locations
Show Show 23 study locations
Sponsors and Collaborators
Spanish Society of Cardiology
Fondo de Investigacion Sanitaria
Sanofi
Cordis Corporation
Medtronic
Guidant Corporation
Boston Scientific Corporation
Investigators
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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)

Publications of Results:
Other Publications:
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Responsible Party: Héctor Bueno, (Past) President. WG on IHD, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT00257309    
Other Study ID Numbers: EUDRACT 2004-001943-31
FIS PI042122
First Posted: November 22, 2005    Key Record Dates
Results First Posted: January 19, 2017
Last Update Posted: January 19, 2017
Last Verified: November 2016
Keywords provided by Héctor Bueno, Spanish Society of Cardiology:
Acute myocardial infarction
Elderly
Thrombolysis
Primary angioplasty
Randomized trial
Efficacy
Safety
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Clopidogrel
Platelet Aggregation Inhibitors
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