Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.
This is a prospective, randomized study conducted in patients undergoing coronary revascularization procedures (PCI) through angioplasty. All patients who meet the eligibility criteria will be randomized to receive, before the procedure, an oral aspirin reload (325 mg) and to be re-evaluated at 60 minutes, 120 minutes, 6 hours, 48 hours, 5 and 30 day, 3 and 6 months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Preprocedural Asprin Reload for Native Coronary Disease Treated by Angioplasty: Reperfusion Indexes Evaluation and Improvement of Clinical Outcome -PANTAREI Study|
- Evaluation of pre procedural aspirin overload effect on markers of platelet activation after percutaneous coronary intervention (PCI) [ Time Frame: Change from baseline at 120 minutes ] [ Designated as safety issue: Yes ]Changes from the baseline of platelet activation markers (thromboxane) after 60, 120 minutes and 6 hours from the end of percutaneous coronary intervention.
- Reperfusion Index [ Time Frame: At the end of the procedure (an expected average of 30 minutes) ] [ Designated as safety issue: Yes ]Changes of TFC and MBG (used to assess myocardial perfusion) before and after PCI.
- Myocardial damage assessed by mean peak values of cardiac troponin I (cTnI) after the percutaneous coronary procedure. [ Time Frame: Changes from baseline at 6 hours ] [ Designated as safety issue: Yes ]At 60 and 120 minutes and at 6 hours after the procedure a blood sample collection will be performed to evaluate Myocardial necrosis indexes.
|Study Start Date:||January 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Aspirin
All patients who meet the eligibility criteria will be randomized in a 1:1 manner to receive, before the coronary percutaneous procedure, an oral aspirin reload (325 mg)or placebo.
Aspirin 325 mg
Other Name: Aspirin
No Intervention: No intervention
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|Sapienza University of Rome|
|Rome, Italy, 00161|
|Principal Investigator:||Stefania Basili, MD||Sapienza-Univerity of Rome|
|Study Chair:||Violi Francesco, Prof.||Sapienza|
|Principal Investigator:||Gaetano Tanzilli, Prof.||Sapienza|
|Principal Investigator:||Marcello Dominici, MD||Division of Cardiology, Department of Interventional Cardiology, Santa Maria University Hospital, Terni, Italy|