Persantin Preceding Elective PCI - Full Text View

Sponsored by:	Radboud University
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00767663

Purpose

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	Intervention	Phase
Coronary Heart Disease Percutaneous Transluminal Coronary Angioplasty Atherosclerosis	Drug: dipyridamole Drug: placebo	Phase IV

MedlinePlus related topics: Coronary Artery Disease Heart Diseases

Drug Information available for: Dipyridamole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI

Further study details as provided by Radboud University:

Primary Outcome Measures:

Cardiac troponin-I [ Time Frame: before and 8 hours after PCI ] [ Designated as safety issue: No ]

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) [ Time Frame: 3 days treatment minimal ] [ Designated as safety issue: No ]
Effect of PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9) [ Time Frame: before and 8 hours after PCI ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2008
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental dipyridamole	Drug: dipyridamole dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
2: Placebo Comparator placebo	Drug: placebo placebo twice daily, minimal three days pretreatment

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767663

Contacts

Contact: Stijn Wouters, MD	+31 24 3616723	c.wouters@cardio.umcn.nl
Contact: Anja Rasing, BSc	+31 24 3611111 ext 1275	A.Rasing-Hoogveld@ncmls.ru.nl

Locations

Netherlands
RUNMC	Recruiting
Nijmegen, Netherlands, 6500HB
Contact: Stijn Wouters, MD +31 24 3616723 c.wouters@cardio.umcn.nl
Principal Investigator: Gerard Rongen, MD PhD

Sponsors and Collaborators

Radboud University

Investigators

Principal Investigator:

Gerard Rongen, MD PhD

RUNMC

More Information

Publications:

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. No abstract available.

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.

Responsible Party:	RUNMC ( G. Rongen MD PhD )
Study ID Numbers:	P3
Study First Received:	October 6, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00767663
Health Authority:	Netherlands: Medical Ethics Review Committee (METC); Netherlands: Medicines Evaluation Board (MEB)

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Dipyridamole
Coronary Artery Disease

Additional relevant MeSH terms:

Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Platelet Aggregation Inhibitors
Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009