Persantin Preceding PCI - P3

Phase 1

Active, not recruiting

• Conditions: myocardial damage due to PCI; MedDRA version: 9.1Level: LLTClassification code 10065554Term: Myocardial infarction prophylaxis

• Registration Number: EUCTR2007-004620-20-NL
• Lead Sponsor: department of Pharmacology-Toxicology RUNMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-30
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

·Patients accepted for elective single, native vessel (left anterior descending, right coronary artery or ramus circumflexus (LAD, RCA or RCX)) PCI in the RUNMC or RUNMC cardiology policlinic patients undergoing diagnostic coronary angiography.
·Troponin-I < 0,20 mmol/L at screening
·Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

·unstable angina
·recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion
·3-Vessel disease as seen on coronary angiogram
·Stenotic laesion in mainstem as seen on coronary angiogram
·CABG in medical history
·asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
·Diabetes Mellitus type I (insuline dependent)
·Use of prescribtioned oral anticoagulants (coumarine derivates)
·Use of oral corticosteroids
·Use of sulfonylurea derivates (glibenclamide, tolbutamide, gliclazide, glimepiride)
·Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID’s)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified