Early Percutaneous Coronary Intervention (PCI) After Fibrinolysis Versus Standard Therapy in ST Segment Elevation Myocardial Infarction (STEMI) Patients
|ClinicalTrials.gov 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
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|
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|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|
Routine invasive strategy with early PCI performed in STEMI patients within 24 hours from successful fibrinolysis
Standard therapy in STEMI patients with fibrinolysis and/or conventional ischaemic-guided therapy.
- Combined death/reinfarction [ Time Frame: 30 days ]
- Death, reinfarction, recurrent ischemia and urgent revascularization [ Time Frame: 30 days ]
- Combined death/reinfarction/recurrent ischemia/urgent revascularization and new presentation CHF and shock [ Time Frame: 30 days. ]
- Major bleeding and hemorrhagic stroke [ Time Frame: 30 days ]
- Combined death/reinfarction and combined revascularization/recurrent ischemia [ Time Frame: 6-12 months ]
- Influence of Optimal Timing of Post-Thrombolysis early revascularization on primary and secondary clinical end-points [ Time Frame: 0-24 hours from thrombolysis ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014182
|Contact: Carlo Di Mario, MD||0044 20 7351 ext firstname.lastname@example.org|
|Royal Brompton Hospital||Recruiting|
|London, United Kingdom, SW6 3NP|
|Contact: Carlo Di Mario 0044 20 7351 ext 8616 email@example.com|