Early Percutaneous Coronary Intervention (PCI) After Fibrinolysis Versus Standard Therapy in ST Segment Elevation Myocardial Infarction (STEMI) Patients

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. Identifier: NCT01014182
Recruitment Status : Unknown
Verified November 2009 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : November 16, 2009
Last Update Posted : November 16, 2009
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust

Brief Summary:

Several recent trials (1,2) suggest that all STEMI patients receiving fibrinolysis in non-PCI centres should be routinely transferred for elective early PCI within 24 hours from hospitalization, with no additive risk of major bleeding complications or other severe adverse events compared standard therapy. These results in favour of a routine invasive strategy in STEMI patients suggest a potential change to the current approach of awaiting the response to treatment in patients receiving fibrinolysis, and draw the attention to the potential need for an appropriate network organization with adequate first hospitalization treatment (spoke) and prompt transfer to centres with 24/7 PCI capabilities (hub). The recent ESC (3) and ACC (4) guidelines on STEMI are consistent with the early ESC PCI Guidelines, recommending that angioplasty after fibrinolysis should be performed within a time-window ranging between 3 and 24 hours after successful lytic administration (level evidence IIA). The reason for the weighting of the recommendation is due to the heterogeneity of trial results with different planned-revascularization strategies, variable primary end-points definitions, and small individual trial sample sizes. Therefore, a consistent analysis of single patient dataset from all published randomized trials would be of value to better define the magnitude and duration of clinical benefit of the routine invasive strategy after lytic treatment as well as the potential optimal timing of such a strategy.

The main aim of the OTTER meta-analysis is to define the benefits of immediate PCI after fibrinolysis for STEMI patients. Moreover, the OTTER meta-analysis will investigate the optimal timing of post-fibrinolysis elective revascularization.

Condition or disease
Myocardial Infarction

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 3000 participants
Official Title: Early Invasive Strategy After Fibrinolysis vs Standard Management in STEMI Patients: Results From an Individual Patient Data Meta-analysis (OTTER Meta-analysis) OTTER: Optimal Timing for Post-Thrombolysis Elective Revascularization
Study Start Date : November 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Early PCI
Routine invasive strategy with early PCI performed in STEMI patients within 24 hours from successful fibrinolysis
Standard Therapy
Standard therapy in STEMI patients with fibrinolysis and/or conventional ischaemic-guided therapy.

Primary Outcome Measures :
  1. Combined death/reinfarction [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Death, reinfarction, recurrent ischemia and urgent revascularization [ Time Frame: 30 days ]
  2. Combined death/reinfarction/recurrent ischemia/urgent revascularization and new presentation CHF and shock [ Time Frame: 30 days. ]
  3. Major bleeding and hemorrhagic stroke [ Time Frame: 30 days ]
  4. Combined death/reinfarction and combined revascularization/recurrent ischemia [ Time Frame: 6-12 months ]
  5. Influence of Optimal Timing of Post-Thrombolysis early revascularization on primary and secondary clinical end-points [ Time Frame: 0-24 hours from thrombolysis ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
STEMI patients.

Inclusion Criteria:

  • STEMI patients enrolled within 12 hours from onset of symptoms
  • Controlled randomized trials comparing a routine invasive strategy with standard therapy in STEMI patients
  • Modern fibrin-specific therapy in both groups
  • Stenting PCI > 80% of invasive procedures
  • English language

Exclusion Criteria:

  • Cardiogenic shock at presentation
  • Need for concomitant
  • Major surgery
  • Severe chronic renal or hepatic impairment
  • Myocardial infarction within the previous 2 weeks
  • Contraindications to thrombolytic therapy, abciximab, aspirin, or clopidogrel
  • Non randomized trials
  • Single patient data not available
  • Non fibrin-specific lytic therapy
  • Stenting PCI < 80% of invasive procedures
  • Not English language

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 identifier (NCT number): NCT01014182

Contact: Carlo Di Mario, MD 0044 20 7351 ext 8616

United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW6 3NP
Contact: Carlo Di Mario    0044 20 7351 ext 8616   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof.Carlo Di Mario, Royal Brompton & Harefield NHS Foundation Trust Identifier: NCT01014182     History of Changes
Other Study ID Numbers: OTTER220179
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: November 16, 2009
Last Verified: November 2009

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Early PCI
Myocardial Infarction
Optimal revascularization therapy in STEMI patients

Additional relevant MeSH terms:
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases