Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.

NCT01374698 | Completed Phase 4

• 1 other identifier: Sapienza
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Arteriosclerosis

Keywords

PCI; Aspirin; Reload

Outcome Measures

Primary Outcomes (1)

• Evaluation of pre procedural aspirin overload effect on markers of platelet activation after percutaneous coronary intervention (PCI)

  Changes from the baseline of platelet activation markers (thromboxane) after 60, 120 minutes and 6 hours from the end of percutaneous coronary intervention.

  Change from baseline at 120 minutes

Secondary Outcomes (2)

• Reperfusion Index

  At the end of the procedure (an expected average of 30 minutes)

• Myocardial damage assessed by mean peak values of cardiac troponin I (cTnI) after the percutaneous coronary procedure.

  Changes from baseline at 6 hours

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

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.

Drug: Aspirin

No intervention

NO INTERVENTION

No intervention

Interventions

Aspirin DRUG

Aspirin 325 mg

Aspirin

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• De novo native coronary chronic occlusion with a reference diameter equal or superior to 3 mm programmed treatment;
• mg/die oral aspirin treatment for at least 7 days before the procedure;
• Target lesion must be covered with two stent maximum with a maximum length ≤ 33 mm each
• Signed written informed consent

You may not qualify if:

• Aspirin, bisulphate clopidogrel, ticlopidine, heparin, contrast agent or heavy metals known allergy that cannot been medically handled;
• Target occlusion localized inside a previously implanted graft
• Target occlusion localized inside a vessel segment previously underwent stent-positioning
• Target occlusion localized inside a vessel with other occlusion not-to-be treated with the target occlusion same stent(s)
• Target occlusion localized inside a vessel with other occlusions need to be treated with balloon angioplasty
• Other techniques than balloon angioplasty target occlusion pre-treatment such as atherectomy, laser intervention or thrombectomy
• Coronary brachytherapy treated patients
• Ejection fraction equal or minor to 30%
• Renal insufficiency (creatinine \>3.0 mg/dl)
• Warfarin-treated patients
• Life expectancy minor to 12 months
• Heart transplanted patients
• Patients still enrolled in some other study, both pharmacological both not

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sapienza University of Rome

Rome, 00161, Italy

Location

Related Publications (1)

• Basili S, Tanzilli G, Raparelli V, Calvieri C, Pignatelli P, Carnevale R, Dominici M, Placanica A, Arrivi A, Farcomeni A, Barilla F, Mangieri E, Violi F. Aspirin reload before elective percutaneous coronary intervention: impact on serum thromboxane b2 and myocardial reperfusion indexes. Circ Cardiovasc Interv. 2014 Aug;7(4):577-84. doi: 10.1161/CIRCINTERVENTIONS.113.001197. Epub 2014 Jul 29.

  PMID: 25074252 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Stefania Basili, MD

  Sapienza-Univerity of Rome

  PRINCIPAL INVESTIGATOR

• Violi Francesco, Prof.

  Sapienza

  STUDY CHAIR

• Gaetano Tanzilli, Prof.

  Sapienza

  PRINCIPAL INVESTIGATOR

• Marcello Dominici, MD

  Division of Cardiology, Department of Interventional Cardiology, Santa Maria University Hospital, Terni, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 6, 2011
• First Posted: June 16, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

IT (1)