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
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Does Pretreatment With Persantin Reduce Periprocedural Troponin-I Release in Patients Undergoing Elective Single Vessel PCI

Resource links provided by NLM:


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 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dipyridamole
Drug: dipyridamole
dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment
Other Name: persantin
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Netherlands
Canisius Wilhelmina Hospital
Nijmegen, Netherlands, 6532SZ
RUNMC
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Gerard Rongen, MD PhD RUNMC
  More Information

Publications:
Responsible Party: G. Rongen MD PhD, RUNMC
ClinicalTrials.gov Identifier: NCT00767663     History of Changes
Other Study ID Numbers: P3
Study First Received: October 6, 2008
Last Updated: August 10, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Medicines Evaluation Board (MEB)

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases
Dipyridamole
Cardiovascular Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase Inhibitors
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on October 22, 2014