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Statins for Blood Clots (SAVER Trial)

Phase 3
Recruiting
Led By Aurélien Delluc, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Symptomatic objectively confirmed proximal leg DVT (above the trifurcation of the popliteal vein) and/or PE (segmental or greater) diagnosed in the last 30 days.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 60 months
Awards & highlights

SAVER Trial Summary

This trial is examining whether adding a statin to the standard treatment for blood clots can reduce the risk of another clot forming, as well as vein damage.

Who is the study for?
This trial is for adults who've had a recent deep vein thrombosis or pulmonary embolism. It's not for those with liver disease, severe kidney issues, on certain medications like cyclosporine, pregnant/breastfeeding women, under 18s, or anyone already taking statins. Participants must be willing to use contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests whether adding rosuvastatin (a cholesterol-lowering drug) to standard blood thinner treatment can prevent new blood clots and reduce vein damage in patients with blood clots. Some participants will receive rosuvastatin while others get a placebo tablet that has no active ingredients.See study design
What are the potential side effects?
Rosuvastatin may cause muscle pain, digestive problems, liver enzyme changes leading to liver damage, increased sugar levels which could lead to diabetes onset or worsening of existing diabetes and possible memory loss or confusion.

SAVER Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a recent diagnosis of a significant blood clot in my leg or lung.

SAVER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrent Major VTE
Secondary outcome measures
Number of deaths during study participation
Number of participants diagnosed with an arterial vascular event during follow-up
Number of participants diagnosed with non-major VTE during follow-up
+1 more
Other outcome measures
Number of participants who have a bleeding event during follow-up

Side effects data

From undefined Phase 3 trial • 1445 Patients • NCT00300482
12%
Headache
7%
Back pain
5%
Nausea
5%
Dizziness
5%
Pain in extremity
4%
Upper respiratiory tract infection
4%
Arthralgia
4%
Sinusitis
3%
Constipation
3%
Diarrhea
3%
Dyspepsia
3%
Myalgia
3%
Pain
2%
Fatigue
2%
Nasopharyngitis
2%
Alanine aminotransferase increased
2%
Cough
2%
Blood creatine phosphokinase increased
2%
Insomnia
1%
Aspartate aminotransferase increased
1%
Stomach discomfort
1%
Breast cancer
1%
Muscle spasms
1%
Osteoarthritis
1%
Pharyngolaryngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
ABT-335
10 mg Rosuvastatin
ABT-335 + 10 mg Rosuvastatin
ABT-335 + 20 mg Rosuvastatin
20 mg Rosuvastatin
40 mg Rosuvastatin

SAVER Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RosuvastatinExperimental Treatment1 Intervention
Participants randomized to the experimental arm will take one rosuvastatin 20 mg tablet by mouth every day for the duration of their participation in the study.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to the control arm will take one placebo tablet by mouth every day for the duration of their participation in the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rosuvastatin Calcium
2008
Completed Phase 3
~1570

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,782,991 Total Patients Enrolled
11 Trials studying Deep Vein Thrombosis
4,089 Patients Enrolled for Deep Vein Thrombosis
Aurélien Delluc, MDPrincipal InvestigatorOttawa Hospital Research Institute

Media Library

Rosuvastatin Calcium Clinical Trial Eligibility Overview. Trial Name: NCT04319627 — Phase 3
Deep Vein Thrombosis Research Study Groups: Rosuvastatin, Placebo
Deep Vein Thrombosis Clinical Trial 2023: Rosuvastatin Calcium Highlights & Side Effects. Trial Name: NCT04319627 — Phase 3
Rosuvastatin Calcium 2023 Treatment Timeline for Medical Study. Trial Name: NCT04319627 — Phase 3

Frequently Asked Questions

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

How many willing test subjects are there for this experiment?

"That is accurate. The current status of the clinical trial can be found on clinicaltrials.gov. According to the most recent update on 9/20/2022, the trial originally posted on 2/10/2021 is still looking for 2700 participants across 10 different sites."

Answered by AI

Are there any similar studies that have used Rosuvastatin Calcium?

"Currently, there are 42 ongoing clinical trials for Rosuvastatin Calcium with 13 of those in Phase 3. Most of the trials for Rosuvastatin Calcium are being conducted in Miami, Florida, but there are 329 locations running trials for Rosuvastatin Calcium."

Answered by AI

Could you please tell me what side effects have been associated with Rosuvastatin Calcium?

"There is some evidence from past trials to support the efficacy of Rosuvastatin Calcium, as well as multiple rounds of data which suggest that it is safe. Therefore, it received a score of 3."

Answered by AI

What are the chief benefits of taking Rosuvastatin Calcium?

"Rosuvastatin Calcium is mostly used to regulate high triglyceride levels, but can also be used to prevent cardiovascular diseases, related events, and surgeries."

Answered by AI
~978 spots leftby Jan 2026