Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.
|ClinicalTrials.gov Identifier: NCT01374698|
Recruitment Status : Completed
First Posted : June 16, 2011
Last Update Posted : May 14, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Arteriosclerosis||Drug: Aspirin||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Preprocedural Asprin Reload for Native Coronary Disease Treated by Angioplasty: Reperfusion Indexes Evaluation and Improvement of Clinical Outcome -PANTAREI Study|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2012|
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
No Intervention: No intervention
- 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 ]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) ]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 ]At 60 and 120 minutes and at 6 hours after the procedure a blood sample collection will be performed to evaluate Myocardial necrosis indexes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374698
|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|