P3: Persantin Preceding Elective PCI

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00767663

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Percutaneous Transluminal Coronary Angioplasty Atherosclerosis	Drug: dipyridamole Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 dipyridamole	Drug: dipyridamole dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment Other Names: persantin
Placebo Comparator: 2 placebo	Drug: placebo placebo twice daily, minimal three days pretreatment

Arm

Intervention/Treatment

Experimental: 1

dipyridamole

Drug: dipyridamole

dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment

Other Names:

persantin

Placebo Comparator: 2

placebo

Drug: placebo

placebo twice daily, minimal three days pretreatment

Outcome Measures

Primary Outcome Measures

Cardiac troponin-I [before and 8 hours after PCI]

Secondary Outcome Measures

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)