This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective Coronary Artery Bypass Grafting (CABG)?

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
G. Rongen, Radboud University
ClinicalTrials.gov Identifier:
NCT01295567
First received: February 1, 2011
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

Rationale:

Due to western lifestyle human coronary arteries are prone to develop atherosclerotic plaques. Hence the heart is an important target organ for atherothrombotic complications: myocardial ischemia, arrhythmias, myocardial infarction and heart failure. To alleviate symptoms and decrease mortality in these patients, myocardial revascularisation is recommended. Coronary artery bypass grafting (CABG) is indicated in patients with severe atherosclerotic disease of all three coronary arteries or the left main stem coronary artery. Cardiac ischemia and reperfusion injury during CABG is inevitable and jointly accountable for complications that occur after CABG (e.g. death, myocardial infarction, arrhythmias, stroke, or renal complications). Dipyridamole has been shown to reduce ischemia reperfusion injury in healthy volunteers using an intermediate endpoint and may prevent cardiovascular death or event in secondary prevention after cerebrovascular disease. The investigators hypothesise that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury due to CABG. The investigators expect lower troponin-I release in patients who were pretreated with dipyridamole.

Objective: To study the effect of oral pretreatment with dipyridamole on high sensitivity (HS)-troponin-I release after CABG. Secondary objectives are whether oral pretreatment with dipyridamole reduces postoperative CABG arrhythmias, prolonged inotropic support, and duration of Intensive Care-stay. Further secondary endpoints are the effects of dipyridamole pretreatment on renal injury and post-ischemic recovery of contractile function (measured ex-vivo).

Hypothesis:

The investigators hypothesize that oral pre-treatment with dipyridamole can increase cardiac tissue tolerance against ischemia and reperfusion injury. The investigators expect lower HS-troponin-I release in patients who were pretreated with dipyridamole. Additionally the investigators expect the incidence of arrhythmias, need for prolonged inotropic support (longer than 24 hours postoperative) to be decreased in pretreated patients.


Condition Intervention Phase
Cardiovascular Disease Ischemic Heart Disease Drug: Dipyridamole Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Dipyridamole Induce Protection Against Ischemia and Reperfusion Injury in Patients Undergoing Elective CABG?

Resource links provided by NLM:


Further study details as provided by G. Rongen, Radboud University:

Primary Outcome Measures:
  • HS-troponin-I [ Time Frame: within 72 hours after CABG. ]
    high sensitivity cardiac troponin-I


Secondary Outcome Measures:
  • duration of inotropic support [ Time Frame: within three days after CABG ]
  • duration of IC stay [ Time Frame: within three days after CABG ]
  • drain production [ Time Frame: 24 hours after surgery and total drain production within three days after surgery ]
    thoracic drain production after CABG

  • post-ischemic recovery of contractile function [ Time Frame: until 4 hours after harvesting ]
    The right atrial appendage is harvested during cardiac surgery before the introduction of the extracorporal circulation. Two atrial trabeculae are dissected, suspended in an organ bath, and linked to a force transducer. after equilibration and baseline measurement, simulated ischemia and reperfusion influences contractile force recovery

  • Renal damage [ Time Frame: Within three days after CABG ]
    biomarkers for renal failure will be detemined in blood and urine before and after CABG


Enrollment: 95
Study Start Date: December 2009
Study Completion Date: September 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo Drug: placebo
prior to CABG surgery 3 day treatment with placebo capsules twice daily
Experimental: dipyridamole Drug: Dipyridamole
prior to CABG surgery 3 day treatment with dipyridamole 200mg SR twice daily
Other Name: persantin

  Eligibility

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

Inclusion Criteria:

  • Acceptation for CABG in RUNMC
  • Informed consent

Exclusion Criteria:

  • Recent myocardial infarction (STEMI or non-STEMI), during two weeks prior to inclusion
  • Asthma
  • Use of insulin
  • Use of sulfonylurea derivates (e.g. glibenclamide, tolbutamide, gliclazide, glimepiride)
  • Use of metformin
  • Use of oral corticosteroids
  • Use of dipyridamole
  • Use of clopidogrel within 8 days prior to scheduled CABG surgery
  • Chronic use of Non Steroid Anti-Inflammatory Drugs (NSAIDs)
  • Off-pump surgery
  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: NCT01295567

Locations
Netherlands
RUNMC
Nijmegen, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: G. Rongen, professor, Radboud University
ClinicalTrials.gov Identifier: NCT01295567     History of Changes
Other Study ID Numbers: dipy-cabg
2009-014299-22 ( EudraCT Number )
Study First Received: February 1, 2011
Last Updated: January 8, 2013

Keywords provided by G. Rongen, Radboud University:
ischemia reperfusion injury
CABG
dipyridamole
HS-troponin-I

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Reperfusion Injury
Pathologic Processes
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Postoperative Complications
Dipyridamole
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Vasodilator Agents

ClinicalTrials.gov processed this record on June 28, 2017