NCT01164540

Brief Summary

This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant treatment will decrease the risk of recurrent venous thromboembolism and arterial thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2011

Status
withdrawn

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

July 8, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

2.1 years

First QC Date

July 8, 2010

Last Update Submit

December 9, 2010

Conditions

Venous ThrombosisPulmonary Embolism

Keywords

Deep venous thrombosisPulmonary embolismrosuvastatin treatment

Outcome Measures

Primary Outcomes (1)

  • Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE))

    Time to first occurrence in the overall treatment period, with a median treatment period of 9,5 months

Secondary Outcomes (2)

  • All cause mortality

    Time to occurrence in the overall treatment period, with a median treatment period of 9,5 months

  • Any event of the composite of venous thromboembolism or arterial thromboembolism/major adverse cardiovascular event (MACE)

    Time to first occurrence in the overall treatment period and during the "on Vitamin K Antagonist (VKA)" treatment period

Study Arms (2)

1

EXPERIMENTAL

Oral Treatment

Drug: Rosuvastatin (AZD4522)

2

PLACEBO COMPARATOR

Oral treatment

Drug: Placebo

Interventions

Rosuvastatin (AZD4522)DRUG

Oral dose (od) 20 mg

Also known as: Crestor
1
PlaceboDRUG

Oral dose (od)

2

Eligibility Criteria

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

You may qualify if:

  • Signed informed Consent.
  • Patients with venous thromboembolism who are treated with anti-coagulant according to the current guidelines

You may not qualify if:

  • Patients in need of or already treated with lipid lowering drugs
  • Active liver or kidney disease or dysfunction or muscle disorders
  • Unstable medical or psychological condition that interferes with study participation
  • Pregnant woman or woman with childbearing potential who are not willing to use contraception
  • History of statin-related muscular pain, or hypersensitivity to statins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venous ThrombosisPulmonary Embolism

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesLung DiseasesRespiratory Tract DiseasesEmbolism

Intervention Hierarchy (Ancestors)

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

Study Officials

  • H. R. Büller, MD, PhD

    Academic Medical Centre

    PRINCIPAL INVESTIGATOR

  • Michael Cressman, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 16, 2010

Study Start

February 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 10, 2010

Record last verified: 2010-12