Aspirin Reload Before Percutaneous Coronary Intervention: Reperfusion Indexes Evaluation.

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Aspirin

Criteria

Inclusion Criteria:

• De novo native coronary chronic occlusion with a reference diameter equal or superior to 3 mm programmed treatment;

• 100 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

Exclusion Criteria:

• 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