Randomized Control Parallel Trial on the Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention

Randomized Control Parallel Trial on the Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention - Effects of Atorvastatin Loading on Reduction of Myocardial Damage in Patients Undergoing Percutaneous Coronary Intervention in Ogaki Municipal Hospital.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002576

Enrollment

500

Registered

2010-04-01

Start date

2009-10-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Patients with Ischemic Heart Disease Undergoing PCI

Interventions

Eligible patients receive atorvastatin (20mg loading dose given 12-18h before coronary angiography, followed by a further 20mg dose 2h before the procedure). patients are treated with atorvastatin (

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)Patients over 20 years old. (2)Patients with ischemic heart disease undergoing PCI. (3)Patients with LDL-Cholesterol over 70mg/dL. (4)The patients who give an informed consent in writing.

Exclusion criteria

Exclusion criteria: (1)Patients with acute myocardial infarction with ST segment elevation (2)Patients with non&#8211;ST segment elevation acute coronary syndrome with high-risk features warranting emergency coronary angiography (3) Patients with increased plasma liver enzymes(AST or ALT >= 100 IU/L) (4) Patients with left ventricular ejection fraction less than 30% (5) Patients with renal failure (creatinine >3 mg/dl) (6) Patients with a history of liver or muscle disease

Design outcomes

Primary

Measure	Time frame
Major adverse cardiac events (MACE) (Cardiac death, nonfatal myocardial infarction, stroke, target vessel revascularization, slow flow during PCI) from the procedure up to 30 days. myocardial infarction : increase of creatine kinase-MB > 2 times above the upper limit of normal. In patients with elevated baseline levels of creatine kinase-MB, myocardial infarction was defined as a subsequent increase of more than 2-fold in creatine kinase-MB from baseline value. Slow flow :Decline of TIMI Grade more than 1 grade during PCI	—

Measure

Time frame

Major adverse cardiac events (MACE) (Cardiac death, nonfatal myocardial infarction, stroke, target vessel revascularization, slow flow during PCI) from the procedure up to 30 days. *myocardial infarction : increase of creatine kinase-MB > 2 times above the upper limit of normal. In patients with elevated baseline levels of creatine kinase-MB, myocardial infarction was defined as a subsequent increase of more than 2-fold in creatine kinase-MB from baseline value. *Slow flow :Decline of TIMI Grade more than 1 grade during PCI

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Secondary

Measure	Time frame
(1)Any postprocedural increase of markers of myocardial injury above upper limits of normal (creatine kinase-MB, troponin-I). (2) The change from a baseline value of the following clinical markers (creatine kinase-MB, troponin-I, C-reactive protein, malondialdehyde-modified-LDL,LDL-C,HDL-C, apolipoprotein, oxidation stress ). blood sampling periods: (creatine kinase-MB, troponin-I, C-reactive protein);the day before PCI and at 8h and 24h and 30days after intervention. (malondialdehyde-modified-LDL); the day before PCI and at 24h after intervention. (LDL-C,HDL-C, apolipoprotein, oxidation stress); the day before PCI and at 24h and 30days after intervention. (3)The change of the platelet aggregation ability. blood sampling periods : the day before PCI and before PCI and at 24h and 30day after intervention. (4)Evaluation of the plaque by IVUS. (5)The patients with an additional written consent will be followed up for an additional year to investigate the incidence of MACE (primary end-point).	—

Measure

Time frame

(1)Any postprocedural increase of markers of myocardial injury above upper limits of normal (creatine kinase-MB, troponin-I). (2) The change from a baseline value of the following clinical markers (creatine kinase-MB, troponin-I, C-reactive protein, malondialdehyde-modified-LDL,LDL-C,HDL-C, apolipoprotein, oxidation stress ). blood sampling periods: (creatine kinase-MB, troponin-I, C-reactive protein);the day before PCI and at 8h and 24h and 30days after intervention. (malondialdehyde-modified-LDL); the day before PCI and at 24h after intervention. (LDL-C,HDL-C, apolipoprotein, oxidation stress); the day before PCI and at 24h and 30days after intervention. (3)The change of the platelet aggregation ability. blood sampling periods : the day before PCI and before PCI and at 24h and 30day after intervention. (4)Evaluation of the plaque by IVUS. (5)The patients with an additional written consent will be followed up for an additional year to investigate the incidence of MACE (primary end-point).

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Countries

Japan

Contacts

Public ContactYasunori Kanzaki

Ogaki Municipal Hospital Department of Cardiology

0584-81-3341

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026