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Statins

Pitavastatin for Cardiovascular Disease (REPRIEVE Trial)

Phase 3

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured from 2020 to participants' final study visit, approximately for 3 years

Awards & highlights

REPRIEVE Trial Summary

This trial will enroll approximately 7,500 participants.

Eligible Conditions

Cardiovascular Disease
Human Immunodeficiency Virus Infection

REPRIEVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured from 2020 to participants' final study visit, approximately for 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured from 2020 to participants' final study visit, approximately for 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured from 2020 to participants' final study visit, approximately for 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to the first event of a composite of major cardiovascular events

Secondary outcome measures

Calculated fasting low-density lipoprotein (LDL) and non-high-density lipoprotein (HDL) cholesterol level

For substudy: changes in inflammatory markers

For substudy: evidence of non-calcified coronary atherosclerotic plaque (NCP)

+10 more

Side effects data

From 2013 Phase 4 trial • 252 Patients • NCT01301066

Headache

Upper abdominal pain

Blood CK increased

Diarrhoea

Fatigue

Atrial septal defect

Diverticulitis

Enterovesical fistula

Transient ischaemic attack

Multiple fractures

Respiratory failure

Chronic obstructive pulmonary disease

Chest pain

Gastroenteritis

Gastroenteritis viral

Herpes dermatitis

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

Pitavastatin 4 mg QD

Pravastatin 40 mg QD

REPRIEVE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PitavastatinExperimental Treatment1 Intervention

Participants will receive pitavastatin once a day for the entire time they are enrolled in the study.

Group II: PlaceboPlacebo Group1 Intervention

Participants will receive placebo for pitavastatin once a day for the entire time they are enrolled in the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pitavastatin

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalOTHER

2,928 Previous Clinical Trials

13,190,586 Total Patients Enrolled

Kowa Pharmaceuticals America, Inc.Industry Sponsor

3 Previous Clinical Trials

420 Total Patients Enrolled

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,268 Previous Clinical Trials

5,473,363 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other research projects that have used Pitavastatin?

"There are 4 clinical trials ongoing that are researching Pitavastatin. 2 of these trials are in Phase 3. Multiple locations throughout the world, including Beijing and Shanghai, are running these studies."

Answered by AI

Are we still looking for more patients to enroll in this clinical trial?

"The trial mentioned is not recruiting patients at this time, according to the latest information available on clinicaltrials.gov. This particular trial was first posted on March 26, 2015, and was last updated on July 27, 2022. There are, however, 923 other trials that are currently enrolling patients."

Answered by AI

At how many different hospitals is this treatment plan being implemented?

"Currently, patients are being accepted at Vanderbilt Therapeutics (VT) CRS located in Nashville, Tennessee; Johns Hopkins University CRS situated in Baltimore, Maryland; VA New york Harbor Healthcare System (NYHHS), NY Campus CRS based in New York, New York; and 97 other sites."

Answered by AI

If an individual is not yet 30 years old, could they still participate in this clinical trial?

"This study is recruiting patients that are 40 to 75 years old, which 138 other trials are also doing. However, there are 745 trials for patients that are outside of this age range."

Answered by AI

Which type of patient is most likely to respond well to this treatment?

"This study seeks to recruit 7770 individuals with cardiovascular diseases that are between 40 and 75 years old. There are several important eligibility criteria that applicants must meet, which are as follows: having been on antiretroviral therapy (ART) for at least 180 days prior to study entry, being HIV-1 positive, having a CD4+ cell count of greater than 100 cells/mm^3, having fasting low-density lipoprotein (LDL) cholesterol that falls within the following ranges: If ASCVD risk score is less than 7.5%, LDL cholesterol must be less than 190 mg/dL. If ASC"

Answered by AI