Ischemia Reperfusion InjuryPhase 4NCT00457652
Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
A Phase 4 study testing Rosuvastatin in people with Ischemia Reperfusion Injury, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury? Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ischemia Reperfusion Injury
- What is being tested?
- Rosuvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteNetherlands
- Study dates
- Jun 2007to Nov 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- age between 18-50 yrs
- signed informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?
Read the detailed description
Rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a reduction in cardiovascular events. Apart from it's cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. In dogs rosuvastatin increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. We hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5'-nucleotidase and thereby increasing adenosine activity. This protective effect of rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.
- Conditions
- Ischemia Reperfusion Injury
- Being tested
- Rosuvastatin
- Keywords
- Rosuvastatin, Caffeine, Ischemia, Reperfusion
- Medical subject headings
- Reperfusion Injury, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RosuvastatinDrug
7 day treatment rosuvastatin 20mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 7 day treatment rosuvastatin Receives: Drug: Rosuvastatin |
| 2 | Placebo comparator | 7 day treatment placebo Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.
Measured: 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)
Measured: during 10 minutes of ischemic exercise
The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum.
Measured: before and after 7day treatment
The caffeine serum concentration after 24 hour abstinence .
Measured: morning after 24 hours abstinence of caffeine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2007 (estimated)
- Study startJun 2007
- Primary completionSep 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemia Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Gerard Rongen, MD, Phd, Principal investigator, UMCN st. Radboud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00457652
- Sponsor's protocol ID
- Rosuva01
- Status last verified
- Apr 2008
- First submitted
- 4 Apr 2007
- Last updated
- 15 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15623546Meijer 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.
PubMed 19359665
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Caffeine Reduce Rosuvastatin-Induced Protection Against Ischemia-Reperfusion Injury?
- ClinicalTrials.gov ID
- NCT00457652
- Acronym / sponsor ID
- Rosuva01
- Conditions
- Ischemia Reperfusion Injury
- Keywords
- Rosuvastatin, Caffeine, Ischemia, Reperfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 6 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Does caffeine reduce rosuvastatin induced protection against ischemia reperfusion injury?
Detailed description
Rosuvastatin is a proven cholesterol lowering medicine, which hereby is assumed to achieve a reduction in cardiovascular events. Apart from it's cholesterol lowering action, rosuvastatin may also increase tolerance against ischemia-reperfusion injury. In dogs rosuvastatin increases the endogenous concentration of adenosine, by enhancing the activity of the enzyme ecto-5'-nucleotidase, which converts adenosine monophosphate into adenosine. We hypothesize that rosuvastatin increases tolerance against ischemia-reperfusion injury by induction of ecto-5'-nucleotidase and thereby increasing adenosine activity. This protective effect of rosuvastatin can be abrogated by using the adenosine receptor antagonist caffeine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Rosuvastatin7 day treatment rosuvastatin |
| 2 | Placebo comparator | Drug: Rosuvastatin7 day treatment placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- age between 18-50 yrs
- signed informed consent
Key exclusion criteria (11 listed)
- Cardiovascular disease
- Hypertension (systole > 140 mmHg, diastole > 90 mmHg)
- Hypercholesterolemia (fasting total cholesterol > 6,0 mmol/l)
- Drug abuse
- Concomitant medication use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin7 day treatment rosuvastatin 20mg | Drug | 1, 2 |
Primary outcome
The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage.
Time frame: 60 and 240 minutes after ischemic exercise
3 secondary outcomes
Workload (product of 50% of the maximum forearm force and duration of the ischemic exercise)
Time frame: during 10 minutes of ischemic exercise
The effect of one-week treatment of rosuvastatin 20mg once daily on lipid spectrum.
Time frame: before and after 7day treatment
The caffeine serum concentration after 24 hour abstinence .
Time frame: morning after 24 hours abstinence of caffeine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
- Background: PubMed 15623546Rongen 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.
- Derived from this study: PubMed 19359665Meijer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerard Rongen, MD, Phd principal investigator
UMCN st. Radboud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rosuvastatin in people with Ischemia Reperfusion Injury, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The targeting of Technetium 99 labeled Annexin A5 is recorded with a gamma camera as a endpoint measure of ischemia-reperfusion damage. (time frame: 60 and 240 minutes after ischemic exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00457652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2008.