NCT00457652

Brief Summary

Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 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

First Submitted

Initial submission to the registry

April 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

3 months

First QC Date

April 4, 2007

Last Update Submit

April 14, 2008

Conditions

Ischemia Reperfusion Injury

Keywords

RosuvastatinCaffeineIschemiaReperfusion

Outcome Measures

Primary Outcomes (1)

  • The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.

    60 and 240 minutes after ischemic exercise

Secondary Outcomes (3)

  • Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)

    during 10 minutes of ischemic exercise

  • The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum.

    before and after 7day treatment

  • The caffeine serum concentration after 24 hour abstinence .

    morning after 24 hours abstinence of caffeine

Study Arms (2)

1

ACTIVE COMPARATOR

7 day treatment rosuvastatin

Drug: Rosuvastatin

2

PLACEBO COMPARATOR

7 day treatment placebo

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

7 day treatment rosuvastatin 20mg

12

Eligibility Criteria

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

You may qualify if:

  • Male
  • age between 18-50 yrs
  • signed informed consent

You may not qualify if:

  • Cardiovascular disease
  • Hypertension (systole \> 140 mmHg, diastole \> 90 mmHg)
  • Hypercholesterolemia (fasting total cholesterol \> 6,0 mmol/l)
  • Drug abuse
  • Concomitant medication use
  • Inability to perform the ischemic isometric muscle contraction
  • Diabetes Mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
  • Alanine-Amino-Transferase (ALAT) \>90U/L (more than twice the upper level of the normal range)
  • Creatinine Kinase (CK) \>340U/L (more than twice the upper level of the normal range)
  • Participation in any trial concerning medicinal products during the last 60 days prior to this study.
  • Participation in clinical trial involving

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMCN st.Radboud

Nijmegen, Netherlands

Location

Related Publications (2)

  • 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

  • Meijer P, Oyen WJ, Dekker D, van den Broek PH, Wouters CW, Boerman OC, Scheffer GJ, Smits P, Rongen GA. Rosuvastatin increases extracellular adenosine formation in humans in vivo: a new perspective on cardiovascular protection. Arterioscler Thromb Vasc Biol. 2009 Jun;29(6):963-8. doi: 10.1161/ATVBAHA.108.179622. Epub 2009 Apr 9.

    PMID: 19359665DERIVED

MeSH Terms

Conditions

Reperfusion InjuryIschemia

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Gerard Rongen, MD, Phd

    UMCN st. Radboud

    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

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 6, 2007

Study Start

June 1, 2007

Primary Completion

September 1, 2007

Study Completion

November 1, 2007

Last Updated

April 15, 2008

Record last verified: 2008-04

Locations

NL(1)