Ischemia Reperfusion InjuryPhase 4NCT00441597
Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
A Phase 4 study testing atorvastatin in people with Ischemia Reperfusion Injury and Cardiovascular Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm. 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, Cardiovascular Disease
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2007to Mar 2009
- 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 18-50 years
- Informed consent
- Physical able to perform ischemic exercise
Who cannot join
- History of any cardiovascular disease
- Hypertension (in supine position: systole > 140 mmHg, diastole > 90 mmHg)
- Diabetes mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
- Hyperlipidaemia (fasting total cholesterol > 5.5 mmol/l)
- Alanine-Amino-Transferase (ALAT) >90 U/L
- Creatinine Kinase (CK) >440 U/L
Show all 10Show fewer
- Drug or alcohol abuse
- Concommitant chronic use of medication
- Administration of radioactivity in research setting during the last 5 years
- Participation to any drug-investigation during the previous 60 days as checked with VIP check according to CRCN standard procedures
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Radboud University Nijmegen Medical Centre
Nijmegen, 6500 HB
About this study
To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.
Read the detailed description
3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) have been found to reduce cardiovascular events. This protective effect has been traditionally explained by lowering plasma cholesterol and subsequent reduced progression of atherosclerosis. However in animal experiments statins have also shown the ability to induce pharmacologic preconditioning and thereby reduce infarct size. This effect contributes to the beneficial effect of statins on reducing of cardiovascular events. In order to differentiate between these two mechanisms of protection we will study the effect of atorvastatin on ischemia reperfusion damage after a short exposure to atorvastatin, before the lipid lowering effect of atorvastatin becomes apparent.
- Being tested
- atorvastatin
- Keywords
- ischemia reperfusion injury, atorvastatine, preconditioning, cardiovascular disease
- Medical subject headings
- Reperfusion Injury, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called lipitor
atorvastatine 80mg, during 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | first 3 day treatment placebo and 4 weeks later three day treatment with atorvastatin 80 mg Receives: Drug: atorvastatin |
| 2 | Active comparator | first 3 day treatment atorvastatin 80 mg and 4 weeks later three day treatment with placebo Receives: Drug: atorvastatin |
| 3 | No intervention | 3 days treatment with placebo twice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.
Measured: 60 and 240 minutes after ischemic exercise
Secondary outcomes (2)
workload during ischemic exercise
Measured: workload during 10minutes of ischemic exercise
effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels
Measured: fasting lipid levels before and at first day after 3 day treatment with atorvastatin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2009
- Study completionMar 2009
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Gerard Rongen, MD PhD, Principal investigator, RUMCN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441597
- Sponsor's protocol ID
- atorv01
- Status last verified
- Mar 2009
- First submitted
- 28 Feb 2007
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
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 15623546Riksen NP, Smits P, Rongen GA. Ischaemic preconditioning: from molecular characterisation to clinical application--part II. Neth J Med. 2004 Dec;62(11):409-23.
PubMed 15685892
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?
- ClinicalTrials.gov ID
- NCT00441597
- Acronym / sponsor ID
- atorv01
- Keywords
- ischemia reperfusion injury, atorvastatine, preconditioning, cardiovascular disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Mar 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.
To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.
Detailed description
3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) have been found to reduce cardiovascular events. This protective effect has been traditionally explained by lowering plasma cholesterol and subsequent reduced progression of atherosclerosis. However in animal experiments statins have also shown the ability to induce pharmacologic preconditioning and thereby reduce infarct size. This effect contributes to the beneficial effect of statins on reducing of cardiovascular events. In order to differentiate between these two mechanisms of protection we will study the effect of atorvastatin on ischemia reperfusion damage after a short exposure to atorvastatin, before the lipid lowering effect of atorvastatin becomes apparent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: atorvastatinfirst 3 day treatment placebo and 4 weeks later three day treatment with atorvastatin 80 mg |
| 2 | Active comparator | Drug: atorvastatinfirst 3 day treatment atorvastatin 80 mg and 4 weeks later three day treatment with placebo |
| 3 | No intervention | –3 days treatment with placebo twice |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Age 18-50 years
- Informed consent
- Physical able to perform ischemic exercise
Key exclusion criteria (10 listed)
- History of any cardiovascular disease
- Hypertension (in supine position: systole > 140 mmHg, diastole > 90 mmHg)
- Diabetes mellitus (fasting glucose > 7.0 mmol/L or random glucose > 11.0 mmol/L)
- Hyperlipidaemia (fasting total cholesterol > 5.5 mmol/l)
- Alanine-Amino-Transferase (ALAT) >90 U/L
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 |
|---|---|---|
| atorvastatinAlso: lipitoratorvastatine 80mg, during 3 days | Drug | 1, 2 |
Primary outcome
Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury.
Time frame: 60 and 240 minutes after ischemic exercise
2 secondary outcomes
workload during ischemic exercise
Time frame: workload during 10minutes of ischemic exercise
effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels
Time frame: fasting lipid levels before and at first day after 3 day treatment with atorvastatin
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 17 Mar 2009.
- 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.
- Background: PubMed 15685892Riksen NP, Smits P, Rongen GA. Ischaemic preconditioning: from molecular characterisation to clinical application--part II. Neth J Med. 2004 Dec;62(11):409-23.
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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
RUMCN
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 atorvastatin in people with Ischemia Reperfusion Injury and Cardiovascular Disease, 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 4 inclusion and 10 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 17 Mar 2009. 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. 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?
Annexin A 5 targeting in the non dominant thenar muscle after ischemic exercise, as a indicator for ischemia reperfusion injury. (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 NCT00441597, 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 17 Mar 2009.