A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI (TOTAL)
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ClinicalTrials.gov Identifier: NCT01149044 |
Recruitment Status
:
Completed
First Posted
: June 23, 2010
Last Update Posted
: October 20, 2015
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Sponsor:
Population Health Research Institute
Information provided by (Responsible Party):
Dr. Sanjit S. Jolly, Population Health Research Institute
Tracking Information | |||||||
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First Submitted Date ICMJE | June 22, 2010 | ||||||
First Posted Date ICMJE | June 23, 2010 | ||||||
Last Update Posted Date | October 20, 2015 | ||||||
Study Start Date ICMJE | August 2010 | ||||||
Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
The first occurrence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure [ Time Frame: up to 180 days ] | ||||||
Original Primary Outcome Measures ICMJE |
The composite of cardiovascular death, recurrent MI, cardiogenic shock, or new or worsening NYHA Class IV heart failure is the primary outcome at 180 days [ Time Frame: 180 days ] | ||||||
Change History | Complete list of historical versions of study NCT01149044 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Trial of Routine Aspiration Thrombectomy With Percutaneous Coronary Intervention (PCI) Versus PCI Alone in Patients With ST-Segment Elevation Myocardial Infarction (STEMI) Undergoing Primary PCI | ||||||
Official Title ICMJE | TOTAL Trial: A Randomized Trial of Routine Aspiration ThrOmbecTomy With PCI Versus PCI ALone in Patients With STEMI Undergoing Primary PCI | ||||||
Brief Summary | This is an international, randomized, controlled, parallel group study in which patients with ST-Segment Elevation Myocardial Infarction (STEMI) will be allocated to one of the following: Manual aspiration thrombectomy with Percutaneous Coronary Intervention (PCI) or PCI alone. | ||||||
Detailed Description | The hypothesis for TOTAL is that the routine use of manual aspiration thrombectomy with an aspiration catheter (Export®) with PCI compared to PCI alone will reduce the incidence of cardiovascular death, recurrent myocardial infarction, cardiogenic shock, or new or worsening NYHA Class IV heart failure (HF) at 180 days in patients with STEMI undergoing primary PCI. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Procedure: Percutaneous Coronary Intervention with or without manual aspiration thrombectomy | ||||||
Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
10732 | ||||||
Original Estimated Enrollment ICMJE |
4000 | ||||||
Actual Study Completion Date | October 2015 | ||||||
Actual Primary Completion Date | March 2015 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 19 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Greece, Hungary, Korea, Republic of, Macedonia, The Former Yugoslav Republic of, Netherlands, New Zealand, Serbia, Spain, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01149044 | ||||||
Other Study ID Numbers ICMJE | TOTAL Trial | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Dr. Sanjit S. Jolly, Population Health Research Institute | ||||||
Study Sponsor ICMJE | Population Health Research Institute | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Population Health Research Institute | ||||||
Verification Date | October 2015 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |