Japan Statin Treatment Against Recurrent Stroke (J-STARS)

• Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)
• Overall Status: Completed
• CT.gov ID: NCT00221104
• Collaborator: Ministry of Health, Labour and Welfare, Japan (Other), Hiroshima University (Other)
• Enrollment: 1,578
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Although hyperlipidemia is not always the risk factor of stroke, inhibition of 3-hydroxy-3-methylglutaryl-coenzyme A(HMG-CoA) reductase can decrease the incidence of stroke in the patient with ischemic heart disease. The neuroprotective mechanism beyond cholesterol lowering should be expected to attenuate inflammation and atherosclerosis. The present study hypothesizes if pravastatin prevents recurrent stroke in the ischemic stroke patients with safety.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke	Drug: Pravastatin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 1578 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Secondary Prevention With HMG-CoA Reductase Inhibitor Against Stroke
• Study Start Date: Mar 1, 2004
• Actual Primary Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Pravastatin Patient has 10mg oral administration of Pravastatin per day. It starts within one month from their entry and continues every day until the end of the study or its endpoints.	Drug: Pravastatin
No Intervention: No intervention Patient has no intervention.

Outcome Measures

Primary Outcome Measures

1. Incidence Rate of Stroke and TIA [up to 5 years]

   Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)

Secondary Outcome Measures

1. Incidence Rate of Atherothrombotic Infarction [up to 5 years]

   Incidence rate of patients with atherothrombotic infarction

2. Incidence Rate of Lacunar Infarction [up to 5 years]

   Incidence rate of patients with lacunar infarction

3. Incidence Rate of Cardioembolic Infarction [up to 5 years]

   Incidence rate of patients with cardioembolic infarction

4. Incidence Rate of Intracranial Hemorrhage [up to 5 years]

   Incidence rate of patients with intracranial hemorrhage

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Ischemic stroke except for cardiogenic embolism, from 1 month to 3 years after onset

• Hyperlipidemia and total cholesterol level of 180-240mg/dl without the prescription of statin within previous 30 days

• Able to visit outpatient department

• Informed consent on the form.

Exclusion Criteria:

• Ischemic stroke of other determined cause according to the TOAST classification

• Ischemic heart disease and necessary to use statin

• Hemorrhagic disorders

• Platelet count <=100,000/ul within 3 months prior to study start

• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)>= 100IU/L within 3 months prior to study start

• Serum creatinine >=2.0mg/dl within 3 months prior to study start

• A scheduled operation

• The presence of malignant disorder

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hiroshima University	Hiroshima		Japan	734-8551

Sponsors and Collaborators

• Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• Ministry of Health, Labour and Welfare, Japan
• Hiroshima University

Investigators

• Principal Investigator: Masayasu Matsumoto, MD, PhD, Hiroshima University Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Japan Statin Treatment Against Recurrent Stroke (J-STARS) only in Japanese

Publications

None provided.

• Responsible Party: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
• ClinicalTrials.gov Identifier: NCT00221104
• Other Study ID Numbers: J-STARS; C000000207
• First Posted: Sep 22, 2005
• Last Update Posted: Jan 25, 2018
• Last Verified: Jun 1, 2017

• Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan: stroke; brain ischemia; cerebrovascular accident; statin; hydroxymethylglutaryl-CoA reductase inhibitors; cholesterol; hypercholesterolemia; hyperlipidemia; multicenter studies; prospective studies; endpoint determination; randomized controlled trials; recurrence; pravastatin
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Pravastatin

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from March 2004 and February 2009 recruited at 123 clinical sites in Japan
Pre-assignment Detail	Participants were randomly assigned to the pravastatin group or the control with 1:1 allocation rate. The patient allocation was dynamically balanced with the stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence) between the two groups.

Arm/Group Title	Pravastatin Group	Control Group
Arm/Group Description	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
Period Title: Overall Study
STARTED	793	785
COMPLETED	710	709
NOT COMPLETED	83	76

Baseline Characteristics

Arm/Group Title	Pravastatin	Control Group	Total
Arm/Group Description	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.	Total of all reporting groups
Overall Participants	793	785	1578
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	335 42.2%	329 41.9%	664 42.1%
>=65 years	458 57.8%	456 58.1%	914 57.9%
Sex: Female, Male (Count of Participants)
Female	248 31.3%	243 31%	491 31.1%
Male	545 68.7%	542 69%	1087 68.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	793 100%	785 100%	1578 100%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Japan	793 100%	785 100%	1578 100%
Ischemic stroke subtype (participants) [Number]
Atherothrombotic infarction	195 24.6%	206 26.2%	401 25.4%
Lacunar infarction	502 63.3%	504 64.2%	1006 63.8%
Infarction of undetermined etiology	96 12.1%	75 9.6%	171 10.8%
High blood pressure (participants) [Number]
Yes	308 38.8%	309 39.4%	617 39.1%
No	485 61.2%	476 60.6%	961 60.9%
Diabetes mellitus (participants) [Number]
Yes	185 23.3%	184 23.4%	369 23.4%
No	608 76.7%	601 76.6%	1209 76.6%

Outcome Measures

1. Primary Outcome

Title	Incidence Rate of Stroke and TIA
Description	Incidence rate of patients with recurrent stroke of any type or transient ischemic attack (TIA)
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Pravastatin	Control Group
Arm/Group Description	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
Measure Participants	793	785
Number (95% Confidence Interval) [events /100 person-years]	2.56	2.65

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pravastatin, Control Group
	Comments	the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.8234
	Comments
	Method	Stratified log-rank test
	Comments	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.73 to 1.29
	Parameter Dispersion	Type: Value:
	Estimation Comments	the adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

2. Secondary Outcome

Title	Incidence Rate of Atherothrombotic Infarction
Description	Incidence rate of patients with atherothrombotic infarction
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Control Group	Pravastatin
Arm/Group Description	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.
Measure Participants	785	793
Number (95% Confidence Interval) [events /100 person-years]	0.65	0.21

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pravastatin, Control Group
	Comments	the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0047
	Comments
	Method	Stratified log-rank test
	Comments	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 95%; 0.15 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments	The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

3. Secondary Outcome

Title	Incidence Rate of Lacunar Infarction
Description	Incidence rate of patients with lacunar infarction
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Pravastatin	Control Group
Arm/Group Description	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
Measure Participants	793	785
Number (95% Confidence Interval) [events /100 person years]	1.26	1.01

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pravastatin, Control Group
	Comments	the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3075
	Comments
	Method	Stratified log-rank test
	Comments	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

4. Secondary Outcome

Title	Incidence Rate of Cardioembolic Infarction
Description	Incidence rate of patients with cardioembolic infarction
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Pravastatin	Control Group
Arm/Group Description	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
Measure Participants	793	785
Number (95% Confidence Interval) [events /100 person-years]	0.18	0.08

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pravastatin, Control Group
	Comments	the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1986
	Comments
	Method	Stratified log-rank test
	Comments	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	2.36
	Confidence Interval	(2-Sided) 95%; 0.61 to 9.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

5. Secondary Outcome

Title	Incidence Rate of Intracranial Hemorrhage
Description	Incidence rate of patients with intracranial hemorrhage
Time Frame	up to 5 years

Outcome Measure Data

Analysis Population Description

intention to treat

Arm/Group Title	Pravastatin	Control Group
Arm/Group Description	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.	The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
Measure Participants	793	785
Number (95% Confidence Interval) [events /100 person-years]	0.29	0.31

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pravastatin, Control Group
	Comments	the stratification factors at randomization: stroke subtype (atherothrombotic infarction vs. others), high blood pressure (≥150/90 mmHg vs. not), and diabetes mellitus (absence vs. presence)
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.9953
	Comments
	Method	Stratified log-rank test
	Comments	log-rank test adjusted for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.45 to 2.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	The adjusted hazard ratio (HR) and the 95% confidence interval (CI) were calculated by the Cox proportional hazard model with for the stratification factors at randomization: stroke subtype, high blood pressure, and diabetes mellitus

Adverse Events

Time Frame	Mean length of follow-up was 4.89 years.
Adverse Event Reporting Description	In the study AE form of clinical study CRF was not prepared. When serious adverse events (SAEs) in the study period were observed, SAEs were reported to principal investigator. AE/SAE were not observed at this study and those were spontanious reports from investigators. So the number at risk SAE (780) is not consistent with number participated (793). In regards to the Other AE, the meaning of number of participants at risk"0" here is because it were not monitored/ assessed.
Arm/Group Title	Pravastatin Group		Control Group
Arm/Group Description	The administration was initiated within 1 month after randomization, and the treatment was continued until final observation. Diet and exercise therapies were reinforced when the total cholesterol levels consistently exceeded 6·21 mmol/L (240 mg/dL) at routine clinical visits. Increase of pravastatin dose or addition of other non-statin drugs (such as ion exchange resin, eicosapentaenoic acid and ezetimibe) was allowed only when such reinforcements were insufficient. Even under such conditions, use of other statins (such as simvastatin and atorvastatin) was prohibited.		The administration of any statin was prohibited, although use of other non-statin drugs was allowed when necessary.
All Cause Mortality
	Pravastatin Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Pravastatin Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	188/780 (24.1%)		164/785 (20.9%)
Blood and lymphatic system disorders
Anaemia	1/780 (0.1%)		2/785 (0.3%)
Cardiac disorders
Angina pectoris	3/780 (0.4%)		3/785 (0.4%)
Angina unstable	2/780 (0.3%)		6/785 (0.8%)
Aortic valve incompetence	1/780 (0.1%)		0/785 (0%)
Arrhythmia	2/780 (0.3%)		0/785 (0%)
Atrial fibrillation	1/780 (0.1%)		4/785 (0.5%)
Atrioventricular block complete	1/780 (0.1%)		1/785 (0.1%)
Atrioventricular block second d	0/780 (0%)		1/785 (0.1%)
Cardiac failure	6/780 (0.8%)		8/785 (1%)
Cardiac failure congestive	1/780 (0.1%)		1/785 (0.1%)
Cardio-respiratory arrest	2/780 (0.3%)		0/785 (0%)
Coronary artery stenosis	1/780 (0.1%)		2/785 (0.3%)
Hypertrophic cardiomyopathy	0/780 (0%)		1/785 (0.1%)
Myocardial infarction	5/780 (0.6%)		12/785 (1.5%)
Myocardial ischaemia	1/780 (0.1%)		0/785 (0%)
Supraventricular tachycardia	0/780 (0%)		1/785 (0.1%)
Ear and labyrinth disorders
Deafness neurosensory	1/780 (0.1%)		0/785 (0%)
Vertigo	1/780 (0.1%)		2/785 (0.3%)
Vertigo positional	2/780 (0.3%)		1/785 (0.1%)
Sudden hearing loss	0/780 (0%)		1/785 (0.1%)
Eye disorders
Cataract	9/780 (1.2%)		10/785 (1.3%)
Cataract diabetic	0/780 (0%)		1/785 (0.1%)
Eyelid oedema	1/780 (0.1%)		0/785 (0%)
Eyelid ptosis	0/780 (0%)		1/785 (0.1%)
Glaucoma	0/780 (0%)		4/785 (0.5%)
Retinal artery occlusion	0/780 (0%)		1/785 (0.1%)
Retinal vein occlusion	0/780 (0%)		1/785 (0.1%)
Vitreous haemorrhage	0/780 (0%)		1/785 (0.1%)
Gastrointestinal disorders
Abdominal pain	1/780 (0.1%)		0/785 (0%)
Anal polyp	1/780 (0.1%)		0/785 (0%)
Colitis	1/780 (0.1%)		0/785 (0%)
Colitis ischaemic	2/780 (0.3%)		1/785 (0.1%)
Colonic polyp	9/780 (1.2%)		7/785 (0.9%)
Crohn's disease	0/780 (0%)		1/785 (0.1%)
Diverticulitis intestinal haemo	1/780 (0.1%)		0/785 (0%)
Diverticulum intestinal	1/780 (0.1%)		0/785 (0%)
Diverticulum intestinal haemorr	2/780 (0.3%)		1/785 (0.1%)
Duodenal ulcer	1/780 (0.1%)		2/785 (0.3%)
Duodenal ulcer perforation	1/780 (0.1%)		0/785 (0%)
Dysphagia	0/780 (0%)		1/785 (0.1%)
Enterocolitis	1/780 (0.1%)		0/785 (0%)
Gastric polyps	1/780 (0.1%)		1/785 (0.1%)
Gastrointestinal haemorrhage	1/780 (0.1%)		1/785 (0.1%)
Haemorrhoids	1/780 (0.1%)		0/785 (0%)
Ileus paralytic	1/780 (0.1%)		1/785 (0.1%)
Inguinal hernia	3/780 (0.4%)		5/785 (0.6%)
Intestinal obstruction	2/780 (0.3%)		3/785 (0.4%)
Pancreatitis	2/780 (0.3%)		1/785 (0.1%)
Upper gastrointestinal haemorrh	0/780 (0%)		1/785 (0.1%)
Volvulus	1/780 (0.1%)		0/785 (0%)
Vomiting	1/780 (0.1%)		0/785 (0%)
General disorders
Asthenia	1/780 (0.1%)		2/785 (0.3%)
Chest pain	1/780 (0.1%)		0/785 (0%)
Death	43/780 (5.5%)		35/785 (4.5%)
Hernia	1/780 (0.1%)		0/785 (0%)
Malaise	4/780 (0.5%)		0/785 (0%)
Multi-organ failure	0/780 (0%)		1/785 (0.1%)
Oedema	1/780 (0.1%)		0/785 (0%)
Oedema peripheral	0/780 (0%)		1/785 (0.1%)
Pyrexia	3/780 (0.4%)		1/785 (0.1%)
Swelling	1/780 (0.1%)		0/785 (0%)
Therapy responder	1/780 (0.1%)		0/785 (0%)
Disuse syndrome	1/780 (0.1%)		0/785 (0%)
Hepatobiliary disorders
Bile duct stone	0/780 (0%)		2/785 (0.3%)
Cholangitis	2/780 (0.3%)		0/785 (0%)
Cholecystitis	2/780 (0.3%)		2/785 (0.3%)
Cholecystitis acute	1/780 (0.1%)		1/785 (0.1%)
Cholelithiasis	0/780 (0%)		1/785 (0.1%)
Hepatic cirrhosis	0/780 (0%)		1/785 (0.1%)
Hepatic cyst	0/780 (0%)		1/785 (0.1%)
Hepatic failure	0/780 (0%)		1/785 (0.1%)
Hepatic function abnormal	4/780 (0.5%)		1/785 (0.1%)
Jaundice	1/780 (0.1%)		0/785 (0%)
Liver disorder	0/780 (0%)		1/785 (0.1%)
Infections and infestations
Appendicitis	1/780 (0.1%)		1/785 (0.1%)
Bronchitis	3/780 (0.4%)		1/785 (0.1%)
Cellulitis	3/780 (0.4%)		1/785 (0.1%)
Cystitis	1/780 (0.1%)		0/785 (0%)
Diverticulitis	1/780 (0.1%)		0/785 (0%)
Gastroenteritis	0/780 (0%)		2/785 (0.3%)
Hepatitis B	1/780 (0.1%)		0/785 (0%)
Herpes zoster	1/780 (0.1%)		1/785 (0.1%)
Influenza	1/780 (0.1%)		0/785 (0%)
Pneumonia	14/780 (1.8%)		11/785 (1.4%)
Pneumonia mycoplasmal	1/780 (0.1%)		0/785 (0%)
Pulmonary tuberculosis	0/780 (0%)		1/785 (0.1%)
Pyelonephritis	1/780 (0.1%)		0/785 (0%)
Pyelonephritis acute	0/780 (0%)		2/785 (0.3%)
Pyothorax	0/780 (0%)		1/785 (0.1%)
Sepsis	1/780 (0.1%)		1/785 (0.1%)
Sinusitis	0/780 (0%)		1/785 (0.1%)
Urinary tract infection	2/780 (0.3%)		2/785 (0.3%)
Encephalitis brain stem	1/780 (0.1%)		0/785 (0%)
Infected epidermal cyst	0/780 (0%)		1/785 (0.1%)
Enteritis infectious	1/780 (0.1%)		0/785 (0%)
Pneumonia bacterial	1/780 (0.1%)		2/785 (0.3%)
Biliary tract infection	1/780 (0.1%)		0/785 (0%)
Extradural abscess	0/780 (0%)		1/785 (0.1%)
Enterocolitis bacterial	1/780 (0.1%)		0/785 (0%)
Injury, poisoning and procedural complications
Arthropod sting	0/780 (0%)		1/785 (0.1%)
Carbon monoxide poisoning	1/780 (0.1%)		0/785 (0%)
Compression fracture	6/780 (0.8%)		4/785 (0.5%)
Fracture	12/780 (1.5%)		10/785 (1.3%)
Injury	3/780 (0.4%)		2/785 (0.3%)
Joint sprain	1/780 (0.1%)		0/785 (0%)
Median nerve injury	1/780 (0.1%)		0/785 (0%)
Subdural haematoma	1/780 (0.1%)		1/785 (0.1%)
Tendon rupture	1/780 (0.1%)		0/785 (0%)
Contusion	3/780 (0.4%)		1/785 (0.1%)
Post procedural haemorrhage	1/780 (0.1%)		0/785 (0%)
Thermal burn	0/780 (0%)		1/785 (0.1%)
Heat illness	0/780 (0%)		1/785 (0.1%)
Investigations
Blood creatine phosphokinase in	0/780 (0%)		1/785 (0.1%)
Catheterisation cardiac	1/780 (0.1%)		0/785 (0%)
Metabolism and nutrition disorders
Dehydration	2/780 (0.3%)		2/785 (0.3%)
Diabetes mellitus	2/780 (0.3%)		1/785 (0.1%)
Diabetes mellitus inadequate co	8/780 (1%)		3/785 (0.4%)
Hyperglycaemia	1/780 (0.1%)		0/785 (0%)
Hypoglycaemia	3/780 (0.4%)		1/785 (0.1%)
Dyslipidaemia	1/780 (0.1%)		1/785 (0.1%)
Decreased appetite	2/780 (0.3%)		1/785 (0.1%)
Hyperlipidaemia	0/780 (0%)		1/785 (0.1%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/780 (0%)		1/785 (0.1%)
Back pain	2/780 (0.3%)		1/785 (0.1%)
Cervical spinal stenosis	0/780 (0%)		1/785 (0.1%)
Lumbar spinal stenosis	1/780 (0.1%)		3/785 (0.4%)
Muscular weakness	1/780 (0.1%)		0/785 (0%)
Myalgia	2/780 (0.3%)		0/785 (0%)
Osteoarthritis	0/780 (0%)		2/785 (0.3%)
Pain in extremity	1/780 (0.1%)		0/785 (0%)
Rhabdomyolysis	2/780 (0.3%)		1/785 (0.1%)
Rotator cuff syndrome	1/780 (0.1%)		0/785 (0%)
Spinal osteoarthritis	3/780 (0.4%)		0/785 (0%)
Intervertebral disc protrusion	1/780 (0.1%)		1/785 (0.1%)
Intervertebral disc disorder	0/780 (0%)		1/785 (0.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma	1/780 (0.1%)		0/785 (0%)
Adrenocortical carcinoma	1/780 (0.1%)		0/785 (0%)
Bladder cancer	1/780 (0.1%)		0/785 (0%)
Bowen's disease	0/780 (0%)		1/785 (0.1%)
Breast cancer	0/780 (0%)		1/785 (0.1%)
Chronic myeloid leukaemia	0/780 (0%)		1/785 (0.1%)
Colon cancer	1/780 (0.1%)		0/785 (0%)
Gastric cancer	15/780 (1.9%)		6/785 (0.8%)
Hypopharyngeal cancer	1/780 (0.1%)		0/785 (0%)
Laryngeal cancer	1/780 (0.1%)		0/785 (0%)
Lipoma	1/780 (0.1%)		0/785 (0%)
Lymphoma	1/780 (0.1%)		0/785 (0%)
Malignant ascites	0/780 (0%)		1/785 (0.1%)
Neoplasm skin	0/780 (0%)		1/785 (0.1%)
Oesophageal carcinoma	4/780 (0.5%)		1/785 (0.1%)
Ovarian cancer	0/780 (0%)		1/785 (0.1%)
Pancreatic carcinoma	1/780 (0.1%)		2/785 (0.3%)
Rectal cancer	2/780 (0.3%)		3/785 (0.4%)
Rectosigmoid cancer	2/780 (0.3%)		0/785 (0%)
Renal cancer	0/780 (0%)		1/785 (0.1%)
Thymoma	0/780 (0%)		1/785 (0.1%)
Thyroid neoplasm	1/780 (0.1%)		0/785 (0%)
Carcinoid tumour of the duodenu	0/780 (0%)		1/785 (0.1%)
Small intestine carcinoma	2/780 (0.3%)		0/785 (0%)
Lung neoplasm malignant	4/780 (0.5%)		4/785 (0.5%)
Large intestine carcinoma	2/780 (0.3%)		7/785 (0.9%)
Gastric adenoma	1/780 (0.1%)		2/785 (0.3%)
Prostate cancer	4/780 (0.5%)		5/785 (0.6%)
Lip and/or oral cavity cancer	0/780 (0%)		1/785 (0.1%)
Thyroid cancer	0/780 (0%)		1/785 (0.1%)
Gingival cancer	0/780 (0%)		1/785 (0.1%)
Nervous system disorders
Altered state of consciousness	0/780 (0%)		1/785 (0.1%)
Autonomic nervous system imbala	0/780 (0%)		2/785 (0.3%)
Carotid artery stenosis	5/780 (0.6%)		4/785 (0.5%)
Cerebral haemorrhage	11/780 (1.4%)		9/785 (1.1%)
Cerebral infarction	17/780 (2.2%)		19/785 (2.4%)
Cerebrovascular accident	0/780 (0%)		3/785 (0.4%)
Convulsion	2/780 (0.3%)		0/785 (0%)
Dementia	4/780 (0.5%)		3/785 (0.4%)
Dizziness	4/780 (0.5%)		4/785 (0.5%)
Embolic stroke	7/780 (0.9%)		1/785 (0.1%)
Epilepsy	2/780 (0.3%)		4/785 (0.5%)
Guillain-Barre syndrome	0/780 (0%)		1/785 (0.1%)
Headache	3/780 (0.4%)		0/785 (0%)
Hydrocephalus	0/780 (0%)		1/785 (0.1%)
Hypertensive encephalopathy	1/780 (0.1%)		0/785 (0%)
Hypoglycaemic encephalopathy	1/780 (0.1%)		0/785 (0%)
Intracranial aneurysm	1/780 (0.1%)		3/785 (0.4%)
Loss of consciousness	0/780 (0%)		1/785 (0.1%)
Myelopathy	0/780 (0%)		2/785 (0.3%)
Normal pressure hydrocephalus	1/780 (0.1%)		1/785 (0.1%)
Parkinsonism	0/780 (0%)		1/785 (0.1%)
Subarachnoid haemorrhage	2/780 (0.3%)		1/785 (0.1%)
Syncope	1/780 (0.1%)		2/785 (0.3%)
Transient ischaemic attack	7/780 (0.9%)		9/785 (1.1%)
Reversible ischaemic neurologic	0/780 (0%)		1/785 (0.1%)
Lacunar infarction	43/780 (5.5%)		39/785 (5%)
Cubital tunnel syndrome	0/780 (0%)		1/785 (0.1%)
Spinal cord infarction	1/780 (0.1%)		0/785 (0%)
Parkinson's disease	1/780 (0.1%)		3/785 (0.4%)
Cerebral artery stenosis	1/780 (0.1%)		2/785 (0.3%)
Thrombotic cerebral infarction	8/780 (1%)		24/785 (3.1%)
Dementia with Lewy bodies	0/780 (0%)		1/785 (0.1%)
Psychiatric disorders
Completed suicide	3/780 (0.4%)		3/785 (0.4%)
Depression	2/780 (0.3%)		0/785 (0%)
Dissociative disorder	1/780 (0.1%)		0/785 (0%)
Mental disorder	1/780 (0.1%)		0/785 (0%)
Renal and urinary disorders
Azotaemia	0/780 (0%)		1/785 (0.1%)
Calculus ureteric	2/780 (0.3%)		0/785 (0%)
Nephritis	1/780 (0.1%)		0/785 (0%)
Nephrotic syndrome	2/780 (0.3%)		0/785 (0%)
Renal artery stenosis	0/780 (0%)		1/785 (0.1%)
Renal failure	1/780 (0.1%)		3/785 (0.4%)
Renal failure chronic	1/780 (0.1%)		2/785 (0.3%)
Urethral haemorrhage	1/780 (0.1%)		0/785 (0%)
Diabetic nephropathy	0/780 (0%)		1/785 (0.1%)
Renal impairment	1/780 (0.1%)		0/785 (0%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	3/780 (0.4%)		1/785 (0.1%)
Breast mass	1/780 (0.1%)		0/785 (0%)
Prostatitis	0/780 (0%)		2/785 (0.3%)
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/780 (0.1%)		0/785 (0%)
Chronic obstructive pulmonary d	1/780 (0.1%)		0/785 (0%)
Emphysema	1/780 (0.1%)		0/785 (0%)
Haemoptysis	0/780 (0%)		1/785 (0.1%)
Haemothorax	0/780 (0%)		1/785 (0.1%)
Interstitial lung disease	1/780 (0.1%)		1/785 (0.1%)
Laryngeal oedema	0/780 (0%)		1/785 (0.1%)
Nasal septum deviation	0/780 (0%)		1/785 (0.1%)
Pleurisy	2/780 (0.3%)		1/785 (0.1%)
Pneumonia aspiration	3/780 (0.4%)		4/785 (0.5%)
Pneumothorax	0/780 (0%)		1/785 (0.1%)
Pulmonary alveolar haemorrhage	0/780 (0%)		1/785 (0.1%)
Pulmonary fibrosis	0/780 (0%)		1/785 (0.1%)
Pulmonary infarction	0/780 (0%)		1/785 (0.1%)
Respiratory failure	0/780 (0%)		1/785 (0.1%)
Sleep apnea syndrome	1/780 (0.1%)		0/785 (0%)
Epiglottic cyst	1/780 (0.1%)		0/785 (0%)
Organising pneumonia	1/780 (0.1%)		0/785 (0%)
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/780 (0.1%)		0/785 (0%)
Drug eruption	1/780 (0.1%)		0/785 (0%)
Eczema	1/780 (0.1%)		0/785 (0%)
Pemphigus	0/780 (0%)		1/785 (0.1%)
Rash	1/780 (0.1%)		0/785 (0%)
Urticaria	1/780 (0.1%)		1/785 (0.1%)
Social circumstances
Social stay hospitalisation	0/780 (0%)		1/785 (0.1%)
Surgical and medical procedures
Hip arthroplasty	0/780 (0%)		1/785 (0.1%)
Gastrostomy	1/780 (0.1%)		0/785 (0%)
Coronary angioplasty	1/780 (0.1%)		1/785 (0.1%)
Hepatectomy	0/780 (0%)		1/785 (0.1%)
Removal of foreign body	1/780 (0.1%)		0/785 (0%)
Laminaplasty	1/780 (0.1%)		0/785 (0%)
Percutaneous coronary intervent	0/780 (0%)		1/785 (0.1%)
Vascular disorders
Aortic aneurysm	4/780 (0.5%)		3/785 (0.4%)
Aortic dissection	3/780 (0.4%)		0/785 (0%)
Arteriosclerosis	0/780 (0%)		1/785 (0.1%)
Hypertension	1/780 (0.1%)		1/785 (0.1%)
Thrombophlebitis migrans	0/780 (0%)		1/785 (0.1%)
Varicose vein	0/780 (0%)		1/785 (0.1%)
Subclavian artery stenosis	1/780 (0.1%)		0/785 (0%)
Peripheral artery aneurysm	0/780 (0%)		1/785 (0.1%)
Aortic rupture	1/780 (0.1%)		0/785 (0%)
Infarction	0/780 (0%)		1/785 (0.1%)
Artery dissection	0/780 (0%)		1/785 (0.1%)
Arterial occlusive disease	1/780 (0.1%)		1/785 (0.1%)
Arteriosclerosis obliterans	3/780 (0.4%)		3/785 (0.4%)
Other (Not Including Serious) Adverse Events
	Pravastatin Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.