Status:
UNKNOWN
Comparison of Primary PCI vs. Post-thrombolysis PCI as Reperfusion Strategies in STEMI
Lead Sponsor:
GRACIA Group
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The conceptual hypothesis of this study is that primary angioplasty is superior to a combined strategy of immediate thrombolysis followed by routine angioplasty in patients with ST-segment elevation a...
Detailed Description
This is a randomized, multicenter, open-label clinical trial comparing two strategies of reperfusion in STEMI. Patients will be randomly allocated to: primary angioplasty or post-thrombolysis angiopla...
Eligibility Criteria
Inclusion
- Age \>18 years
- Chest discomfort \> 30 minutes with no response to nitroglycerin
- Time from the onset of symptoms to randomization between 0 and 12 hours
- ST segment elevation \> 1 mm in two or more contiguos precordial leads or non-diagnostic ECG (left bundle branch block or pacemarker rhythm) with classic symptoms.
- Killip class equal or less than 3
- Written informed consent
Exclusion
- Cardiogenic shock defined as a systolic blood pressure \<90 mm Hg without response to fluid administration or \<100 mm Hg in patients with supportive treatment and no bradycardia
- Suspicion or evidence of mechanical complications of STEMI
- Non-cardiac disease that is likely to jeopardize compliance with follow-up schedule of the study (life expectancy \< 1 year)
- woman of childbearing potential unless a negative pregnant test
- Major contraindications for thrombolytic therapy
- Participation in other trial
- Known multivessel disease identified as unsuitable for revascularization
- Known peripheral vascular disease that complicates cardiac catheterization
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
1444 Patients enrolled
Trial Details
Trial ID
NCT02268669
Start Date
May 1 2010
End Date
March 1 2016
Last Update
October 20 2014
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