Persantin Preceding Elective PCI (P3)

This study has suspended participant recruitment.
(enrollment difficulties)
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00767663
First received: October 6, 2008
Last updated: August 10, 2011
Last verified: July 2011

October 6, 2008
August 10, 2011
October 2008
May 2012   (final data collection date for primary outcome measure)
Cardiac troponin-I [ Time Frame: before and 8 hours after PCI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00767663 on ClinicalTrials.gov 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 ] [ 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 ]
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    dipyridamole
    Intervention: Drug: dipyridamole
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
200
Not Provided
May 2012   (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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00767663
P3
No
G. Rongen MD PhD, RUNMC
Radboud University
Not Provided
Principal Investigator: Gerard Rongen, MD PhD RUNMC
Radboud University
July 2011

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