Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|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|
|Actual Primary Completion Date :||September 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|