Does atorvastatin reduce ischemia-reperfusion injury in humans in-vivo? - ator

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006706-29-NL

Enrollment

Registered

2006-12-22

Start date

2007-02-12

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ischemia reperfusion injury MedDRA version: 8.1 Level: LLT Classification code 10028596 Term: Myocardial infarction

Interventions

Trade Name: Atorvastatine Product Name: Atorvastatine Pharmaceutical Form: Film-coated tablet INN or Proposed INN: atorvastatine CAS Number: 134523-00-5 Concentration unit: mg milligram(s) Concentrat

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Male - Age 18-50 years - Informed consent - Physical able to perform ischemic exercise Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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 (more than twice the upper level of the normal range) - Creatinine Kinase (CK) >340 U/L (more than twice the upper level of the normal range) - Drug abuse - Concomitant 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.;Secondary Objective: workload during ischemic exercise, effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels;Primary end point(s): Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion	—

Measure

Time frame

Main Objective: To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.;Secondary Objective: workload during ischemic exercise, effect of 3-day treatment with atorvastatin 80mg daily on serum lipid levels;Primary end point(s): Percentage difference in radioactivity (counts/pixel) between experimental and control thenar muscle at 60 and 240 minutes after reperfusion

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026