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Persantin Preceding Elective PCI (P3)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00767663
Recruitment Status : Completed
First Posted : October 7, 2008
Last Update Posted : October 30, 2015
Information provided by (Responsible Party):
G. Rongen, Radboud University

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:


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.


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


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.

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Study Type : Interventional  (Clinical Trial)
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 : October 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Drug: dipyridamole
dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
Other Name: persantin

Placebo Comparator: 2
Drug: placebo
placebo twice daily, minimal three days pretreatment

Primary Outcome Measures :
  1. Cardiac troponin-I [ Time Frame: before and 8 hours after PCI ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00767663

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Nijmegen, Netherlands, 6500HB
Canisius Wilhelmina Hospital
Nijmegen, Netherlands, 6532SZ
Sponsors and Collaborators
Radboud University
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Principal Investigator: Gerard Rongen, MD PhD RUNMC
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Responsible Party: G. Rongen, G. Rongen MD PhD, Radboud University Identifier: NCT00767663    
Other Study ID Numbers: P3
First Posted: October 7, 2008    Key Record Dates
Last Update Posted: October 30, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents