Persantin Preceding Elective PCI

Atherosclerosis Clinical Trial

— P3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767663
• Other study ID #: P3
• Status: Completed
• Phase: Phase 4
• First received: October 6, 2008
• Last updated: October 29, 2015
• Start date: October 2008
• Est. completion date: February 2010

Study information

• Verified date: October 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: Medicines Evaluation Board (MEB)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Myocardial Ischemia
• Percutaneous Transluminal Coronary Angioplasty

Intervention

Drug:
• dipyridamole
dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
• placebo
placebo twice daily, minimal three days pretreatment

Locations

Country	Name	City	State
Netherlands	Canisius Wilhelmina Hospital	Nijmegen
Netherlands	RUNMC	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

ESPRIT Study Group, Halkes PH, van Gijn J, Kappelle LJ, Koudstaal PJ, Algra A. Aspirin plus dipyridamole versus aspirin alone after cerebral ischaemia of arterial origin (ESPRIT): randomised controlled trial. Lancet. 2006 May 20;367(9523):1665-73. Erratum in: Lancet. 2007 Jan 27;369(9558):274. — View Citation

Kleiman NS. Measuring troponin elevation after percutaneous coronary intervention: ready for prime time? J Am Coll Cardiol. 2006 Nov 7;48(9):1771-3. Epub 2006 Oct 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac troponin-I		before and 8 hours after PCI	No
Secondary	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	No
Secondary	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	No