Persantin Preceding Elective PCI

Phase 4

Completed

• Conditions: Coronary Heart Disease; Percutaneous Transluminal Coronary Angioplasty; Atherosclerosis
• Interventions: Drug: placebo; Drug: dipyridamole

• Registration Number: NCT00767663
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2010-01
• Study Completion: 2010-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-29
• Last Update Posted: 2015-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	placebo
1	dipyridamole	dipyridamole

Primary Outcome Measures

Name	Time	Method
Cardiac troponin-I	before and 8 hours after PCI

Secondary Outcome Measures

Name	Time	Method
Effect of PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)	before and 8 hours after PCI
Effect of pretreatment with dipyridamole 2x200mg on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)	3 days treatment minimal

Trial Locations

Locations (2)

RUNMC; 🇳🇱 Nijmegen, Netherlands

Canisius Wilhelmina Hospital; 🇳🇱 Nijmegen, Netherlands