NCT00767663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

October 6, 2008

Last Update Submit

October 29, 2015

Conditions

Coronary Heart DiseasePercutaneous Transluminal Coronary AngioplastyAtherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Cardiac troponin-I

    before and 8 hours after PCI

Secondary Outcomes (2)

  • Effect of pretreatment with dipyridamole 2x200mg on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)

    3 days treatment minimal

  • Effect of PCI on biomarkers reflecting vascular inflammation (hs-CRP, PLA2, PTX3, IL-6, adiponectin, MCP-1, MMP-9)

    before and 8 hours after PCI

Study Arms (2)

1

EXPERIMENTAL

dipyridamole

Drug: dipyridamole

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

dipyridamoleDRUG

dipyridamole slow release 200mg twice daily, minimal 3 days pretreatment

Also known as: persantin
1
placeboDRUG

placebo twice daily, minimal three days pretreatment

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unstable angina
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

RUNMC

Nijmegen, 6500HB, Netherlands

Location

Canisius Wilhelmina Hospital

Nijmegen, 6532SZ, Netherlands

Location

Related Publications (2)

  • Kleiman NS. Measuring troponin elevation after percutaneous coronary intervention: ready for prime time? J Am Coll Cardiol. 2006 Nov 7;48(9):1771-3. doi: 10.1016/j.jacc.2006.08.008. Epub 2006 Oct 17. No abstract available.

    PMID: 17084248BACKGROUND

  • 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. doi: 10.1016/S0140-6736(06)68734-5.

    PMID: 16714187BACKGROUND

MeSH Terms

Conditions

Coronary DiseaseAtherosclerosis

Interventions

Dipyridamole

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gerard Rongen, MD PhD

    RUNMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
G. Rongen MD PhD

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

October 1, 2008

Primary Completion

January 1, 2010

Study Completion

February 1, 2010

Last Updated

October 30, 2015

Record last verified: 2015-10

Locations

NL(2)