NCT02679664

Brief Summary

The SAVER pilot is a randomized, open-label pilot study to determine the feasibility of recruitment. In addition to feasibility data, the investigators will carefully collect clinical data to determine if rosuvastatin can reduce post-thrombotic syndrome (PTS) in venous thromboembolism (VTE) patients. Eligible consenting patients who developed acute, symptomatic, and objectively confirmed proximal leg deep vein thrombosis (DVT) and/or PE will be randomized and equally allocated to 2 trial arms, either the treatment group (rosuvastatin tablet (20 mg/day) or the control group (usual care). The pilot trial consists of up to 4 study contacts over 6 months: screening, randomization, telephone follow-up (90 days), and final study visit (180 days).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2016

Typical duration for phase_2

Geographic Reach
2 countries

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

3.2 years

First QC Date

February 1, 2016

Last Update Submit

February 25, 2020

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

  • Number of participants recruited per center per month - [Study Feasibility]

    Study feasibility as indicated by the number of participants recruited per center per month.

    3 years

  • Incidence of PTS

    Incidence of post thrombotic syndrome (PTS), as measured by the Villalta scale at 6 months by both an 'Blinded Independent Assessor' and self reported by the participant.

    180 days (+/- 21 days)

Secondary Outcomes (7)

  • Symptomatic recurrent major VTE

    180 days (+/- 21 days)

  • Components of major VTE

    180 days (+/- 21 days)

  • Non-major VTE

    180 days (+/- 21 days)

  • Arterial Vascular Events

    180 days (+/- 21 days)

  • All-cause mortality

    180 days (+/- 21 days)

  • +2 more secondary outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

20 mg tablet of rosuvastatin PO once-a-day starting at the time of randomization until the completion of follow-up at 6 months.

Drug: Rosuvastatin

Control group

NO INTERVENTION

Standard medical care only. No rosuvastatin group.

Interventions

RosuvastatinDRUG

20 mg tablet of rosuvastatin

Also known as: Generic rosuvastatin, Teva-Rosuvastatin
Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • Unable or unwilling to provide written informed consent
  • ≤ 18 years of age
  • Currently prescribed a statin
  • A medical history or current diagnosis of any of the following:
  • Abdominal aortic aneurysm,
  • Peripheral arterial disease,
  • Stroke,
  • Transient ischemic attack (TIA),
  • Myocardial infarction (MI),
  • Acute coronary syndromes,
  • Stable angina,
  • Coronary or other arterial revascularization
  • LDL-C \>4.91 mmol/L
  • LDL-C between 1.81mmol/L to 4.9mmol/L AND 10 ASCVD risk score \>10%
  • Diabetes mellitus or pre-diabetes
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Nova Scotia Health Authority

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences Corporation

Hamilton, Ontario, Canada

Location

Lawson Health Research Institute, London Health Sciences Centre

London, Ontario, Canada

Location

Ottawa Hospital

Ottawa, Ontario, Canada

Location

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

Location

Østfold Hospital Trust

Grålum, Norway

Location

Related Publications (1)

  • Delluc A, Ghanima W, Kovacs MJ, Shivakumar S, Kahn SR, Sandset PM, Kearon C, Mallick R, Rodger MA. Prevention of post-thrombotic syndrome with rosuvastatin: A multicenter randomized controlled pilot trial (SAVER). Thromb Res. 2022 May;213:119-124. doi: 10.1016/j.thromres.2022.03.014. Epub 2022 Mar 19.

    PMID: 35344784DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Marc Rodger, M.D.

    Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 10, 2016

Study Start

November 1, 2016

Primary Completion

January 13, 2020

Study Completion

July 1, 2020

Last Updated

February 27, 2020

Record last verified: 2020-02

Locations

CA(5)NO(1)