Persantin Preceding Elective PCI

NCT ID: NCT00767663

Last Updated: 2015-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2010-02-28

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.

Conditions

Coronary Heart Disease; Percutaneous Transluminal Coronary Angioplasty; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

1

dipyridamole

Group Type: EXPERIMENTAL

dipyridamole

Intervention Type: DRUG

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

2

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo twice daily, minimal three days pretreatment

Interventions

dipyridamole

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

Intervention Type: DRUG

placebo

placebo twice daily, minimal three days pretreatment

Intervention Type: DRUG

Other Intervention Names

persantin

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

G. Rongen

G. Rongen MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gerard Rongen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

RUNMC

Locations

RUNMC

Nijmegen, , Netherlands

Canisius Wilhelmina Hospital

Nijmegen, , Netherlands

Countries

Netherlands

References

Kleiman NS. Measuring troponin elevation after percutaneous coronary intervention: ready for prime time? J Am Coll Cardiol. 2006 Nov 7;48(9):1771-3. doi: 10.1016/j.jacc.2006.08.008. Epub 2006 Oct 17. No abstract available.

Reference Type: BACKGROUND

PMID: 17084248 (View on PubMed)

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. doi: 10.1016/S0140-6736(06)68734-5.

Reference Type: BACKGROUND

PMID: 16714187 (View on PubMed)

Other Identifiers

P3

Identifier Type: -

Identifier Source: org_study_id