A Phase 4 interventional study of dipyridamole in Ischemia-Reperfusion Injury and Atherosclerosis, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-15.
Sponsored by Radboud University Medical Center · Phase 4, Interventional, and Treatment
This study is performed to determine whether a seven day treatment with dipyridamole (slow release, 200mg twice daily) can induce a protective effect against ischemia-reperfusion injury, after ischemic exercise of the non-dominant forearm in healthy volunteers.
Rationale:
Dipyridamole increases the endogenous adenosine level by inhibition of the nucleoside transporter (ENT-1). Activation of the adenosine receptor protects against ischemia-reperfusion injury (pharmacologic preconditioning).
The purpose of this project is to explore whether a seven day treatment with dipyridamole can reduce ischemia-reperfusion injury in the forearm, in a randomized double blind placebo controlled trial.
Study design:
Randomized double-blind placebo-controlled trial with a cross-over design.
Study population:
Healthy male volunteers, aged 18-50 yr
Intervention:
10 Volunteers will be randomised to receive in a cross-over design either a 7 day treatment with dipyridamole (Persantin retard; 200 mg twice daily) or placebo followed by 10 minutes of ischemic isometric muscle contraction of the non-dominant forearm and upon reperfusion infusion of radiolabeled Annexin A5 (Annexin scintigraphy).
Main study parameters/endpoints:
Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
This study will be executed at the Clinical Research Centre Nijmegen under close medical supervision. Treatment with dipyridamole is not expected to harm the volunteers. During the first days of treatment with dipyridamole, a headache may occur. Ischemic hand gripping will temporarily result in pain in the forearm. This is completely reversible upon reperfusion. Administration of radiolabeled Annexin A5 results in an effective dose of less than 5 mSv, well within the range of accepted exposure to radioactivity for human research. Participation in this research does not interfere with possible diagnostic or therapeutic procedures with X-rays of radioactivity in the future.
Occurrence of an allergic reaction is theoretically possible upon administration of Annexin A5, however there have been no allergic reactions reported in all volunteers exposed to Annexin A5.
The volunteers will not benefit directly from participating in this study.
1,567 studies on the registry are indexed under Atherosclerosis; 264 are open to participants now.
This study's enrollment of 10 is below the median of 106 across 882 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
first 7 day treatment with dipyridamol and at least two weeks later 7 day treatment with placebo
Drug: dipyridamole
first 7 day treatment with placebo and at least two weeks later 7 day treatment with atorvastatin
Drug: dipyridamole
dipyridamole 200mg twice daily
Also known as: persantin
Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion.
Time frame: 60 and 240 minutes after reperfusion
Plasma dipyridamole concentration
Time frame: in the morning of day seven of treatment
Workload (duration of exercise and developed force)
Time frame: during 10 minutes ischemic exercise
Heart rate (preceded by a 7day treatment of dipyridamol or placebo)
Time frame: during 30 minutes at day seven of treatment with dipyridamol and placebo
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center