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Does Caffeine Reduce Dipyridamole-Induced Protection Against Ischemia-Reperfusion Injury?

NCT ID: NCT00430170

Last Updated: 2008-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-04-30

Brief Summary

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The purpose of this project is to explore the interaction between caffeine and dipyridamole on ischemia-reperfusion injury in the forearm.

Detailed Description

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Dipyridamole has been proven to reduce targeting of Annexin A5 in responses to ischemic exercise, indicating protection against ischemia-reperfusion injury in humans (pharmacological preconditioning). Dipyridamole increases the endogenous adenosine level by inhibition of the nucleoside transporter (ENT-1). Activation of the adenosine receptor protects against ischemia-reperfusion injury. We hypothesize that endogenous adenosine mediates the protective effect of dipyridamole against ischemia-reperfusion injury. Therefore the adenosine receptor antagonist caffeine will reduce the benefit of dipyridamole on forearm ischemia-reperfusion injury.

Conditions

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Cardiovascular Disease Ischemia-Reperfusion Injury

Keywords

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ischemia-reperfusion injury adenosine dipyridamole caffeine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

dipyridamol during 7 days and before ischemic exercise caffeine 4mg/kg

Group Type ACTIVE_COMPARATOR

Dipyridamole

Intervention Type DRUG

Dipyridamole 2x200mg 7day per os

caffeine

Intervention Type DRUG

caffeine 4mg/kg iv

2

dipyridamol during 7 days and before ischemic exercise placebo

Group Type PLACEBO_COMPARATOR

Dipyridamole

Intervention Type DRUG

Dipyridamole 2x200mg 7day per os

Interventions

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Dipyridamole

Dipyridamole 2x200mg 7day per os

Intervention Type DRUG

caffeine

caffeine 4mg/kg iv

Intervention Type DRUG

Other Intervention Names

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persatin

Eligibility Criteria

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Inclusion Criteria

* Male
* Age between 18-50yr.

Exclusion Criteria

* cardiovascular disease
* hypertension (systole \> 140 mmHg, diastole \> 90 mmHg)
* hypercholesterolemia (random total cholesterol \> 6.5 mmol/l)
* diabetes mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
* asthma (recurrent episodes of dyspnea and wheezing, or usage of prescribed inhalation medication: i.e. corticosteroids or B2-agonists)
* participation in any clinical trial during the last 60 days prior to this study.
* administration of two doses of Annexin A5 (0,1mg; 450MBq) during the last 5 years prior to this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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dept Pharmacology Toxicology

Principal Investigators

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Gerard Rongen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Radboud University Nijmegen Medical Centre

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Riksen NP, Oyen WJ, Ramakers BP, Van den Broek PH, Engbersen R, Boerman OC, Smits P, Rongen GA. Oral therapy with dipyridamole limits ischemia-reperfusion injury in humans. Clin Pharmacol Ther. 2005 Jul;78(1):52-9. doi: 10.1016/j.clpt.2005.03.003.

Reference Type BACKGROUND
PMID: 16003293 (View on PubMed)

Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.

Reference Type BACKGROUND
PMID: 15623546 (View on PubMed)

Other Identifiers

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dipy001

Identifier Type: -

Identifier Source: org_study_id