Persantin Preceding Elective PCI (P3)

Radboud University Medical Center

Status and phase

Completed

Phase 4

Conditions

Coronary Heart Disease

Atherosclerosis

Percutaneous Transluminal Coronary Angioplasty

Treatments

Drug: placebo

Drug: dipyridamole

Study type

Interventional

Funder types

Other

Identifiers

NCT00767663

Details and patient eligibility

About

In this study the investigators will investigate whether a short pretreatment (3-7 days) with dipyridamole 200mg twice daily will protect patients against myocardial injury sustained during an elective dotter operation of the coronary arteries (PCI).

The investigators hypothesize that dipyridamole can reduce myocardial injury sustained during elective PCI.

Full description

Rationale:

In elective PCI (percutaneous coronary intervention) up to 40% of the patients show an asymptomatic rise in myonecrosis marker troponin-I. This release of troponin-I has been found to represent irreversible myocardial injury and has been related to an increased risk of restenosis and even long-term mortality. Dipyridamole has been proven to induce protection against ischemia reperfusion injury and to reduce risk of cardiovascular death or event in secondary prevention after TIA or CVA.

Objective:

To test the hypothesis that dipyridamole improves tolerance to ischemia reperfusion injury in patients undergoing elective PCI.

Study design:

Double-blind placebo controlled intervention study

Study population:

Patients undergoing elective PCI

Intervention:

pretreatment with dipyridamole (Persantin Retard) 2dd 200mg or placebo.

Main study parameters:

Periprocedural troponin-I release measured 8 hours after PCI.

Bioequivalence study:

before the start of th clinical trial we will perform a bioequivalent study to test whether our study medication (blinded by recapsuling) equals original dipyridamole capsules. 6 Healthy volunteers in a cross-over randomised design will take original dipyridamole 200 mg SR and recapsuled dipyridamole 200mg SR (prepared by the department of pharmacy of the RUNMC). Plasma dipyridamole concentration will be measured frequently and at baseline and 1 and 3 hours after administration of dipyridamole nucleoside transport inhibitions of erythrocytes will be measured, to assess drug activity.

The clinical trial will only be initialized after conformation of bioequivalence of the study medication to the original dipyridamole.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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
Troponin-I < 0,20 mmol/L at screening
Signed Informed consent

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 lesion in main stem as seen on coronary angiogram
CABG in medical history
asthma (recurrent episodes of dyspnoea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
Treatment with insulin
Use of prescribed oral anticoagulants (coumarin derivates)
Use of oral corticosteroids
Use of sulfonylurea derivates (glibenclamide, tolbutamide, gliclazide, glimepiride)
Use of heparin or low molecular weight heparin
Use of metformin
Use of dipyridamole
Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAID's)