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

October 6, 2008
October 7, 2008
October 30, 2015
October 2008
January 2010   (Final data collection date for primary outcome measure)
Cardiac troponin-I [ Time Frame: before and 8 hours after PCI ]
Same as current
Complete list of historical versions of study NCT00767663 on Archive Site
  • 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 ]
  • 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 ]
Same as current
Not Provided
Not Provided
Persantin Preceding Elective PCI
Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI

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.


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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Coronary Heart Disease
  • Percutaneous Transluminal Coronary Angioplasty
  • Atherosclerosis
  • Drug: dipyridamole
    dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
    Other Name: persantin
  • Drug: placebo
    placebo twice daily, minimal three days pretreatment
  • Experimental: 1
    Intervention: Drug: dipyridamole
  • Placebo Comparator: 2
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2010
January 2010   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
G. Rongen, Radboud University
Radboud University
Not Provided
Principal Investigator: Gerard Rongen, MD PhD RUNMC
Radboud University
October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP