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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01014182
First received: November 13, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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
Myocardial Infarction

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Royal Brompton & Harefield NHS Foundation Trust:

Primary Outcome Measures:
  • Combined death/reinfarction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 3000
Study Start Date: November 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

STEMI patients.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014182

Contacts
Contact: Carlo Di Mario, MD 0044 20 7351 ext 8616 c.dimario@rbht.nhs.uk

Locations
United Kingdom
Royal Brompton Hospital Recruiting
London, United Kingdom, SW6 3NP
Contact: Carlo Di Mario    0044 20 7351 ext 8616    c.dimario@rbht.nhs.uk   
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Prof.Carlo Di Mario, Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01014182     History of Changes
Other Study ID Numbers: OTTER220179
Study First Received: November 13, 2009
Last Updated: November 13, 2009
Health Authority: United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014