NCT00430170

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

July 29, 2008

Status Verified

July 1, 2008

Enrollment Period

2 months

First QC Date

January 31, 2007

Last Update Submit

July 28, 2008

Conditions

Cardiovascular DiseaseIschemia-Reperfusion Injury

Keywords

ischemia-reperfusion injuryadenosinedipyridamolecaffeine

Outcome Measures

Primary Outcomes (1)

  • Percentage difference in Annexin A5 targetting between experimental and control thenar muscle at 60 and 240 minutes after reperfusion

    60 and 240 minutes after ischemic exercise

Secondary Outcomes (3)

  • Plasma dipyridamole concentration

    at the morning of day 7 of treatment with dipyridamole/placebo

  • ENT transport activity (before and after treatment with dipyridamole 200mg, twice daily, for seven days)

    before start of treatment (dipyridamol/placebo) and in the morning of day 7 of treatment (placebo/dipyridamol)

  • Workload (duration of exercise and developed force)

    during 10 minutes of ischemic exercise

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: DipyridamoleDrug: caffeine

2

PLACEBO COMPARATOR

dipyridamol during 7 days and before ischemic exercise placebo

Drug: Dipyridamole

Interventions

DipyridamoleDRUG

Dipyridamole 2x200mg 7day per os

Also known as: persatin
12
caffeineDRUG

caffeine 4mg/kg iv

1

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • Age between 18-50yr.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500hb, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 16003293BACKGROUND

  • 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.

    PMID: 15623546BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesReperfusion Injury

Interventions

DipyridamoleCaffeine

Condition Hierarchy (Ancestors)

Vascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsXanthinesAlkaloidsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gerard Rongen, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2007

Study Completion

April 1, 2007

Last Updated

July 29, 2008

Record last verified: 2008-07

Locations

NL(1)