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Venous ThrombosisPhase 3Du LacNCT01164540

Study on the Effect of Rosuvastatin Treatment on the Prevention of Thrombosis in Patients With Previous Thrombosis

A Phase 3 study testing Rosuvastatin (AZD4522) in people with Venous Thrombosis and Pulmonary Embolism, run by AstraZeneca.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thrombosis, Pulmonary Embolism
What is being tested?
Rosuvastatin (AZD4522)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
3,000 participants
Where
No sites listed yet
Study dates
Feb 2011to Mar 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: A Randomised, Double-blind, Placebo-controlled, Event Driven, Phase III Study of Rosuvastatin 20 mg Once Daily in the Long Term Prevention of Recurrent Venous Thromboembolism in Patients With Deep Vein Thrombosis or Pulmonary Embolism

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.

Being tested
Rosuvastatin (AZD4522), Placebo
Keywords
Deep venous thrombosis, Pulmonary embolism, rosuvastatin treatment
Medical subject headings
Venous Thrombosis, Pulmonary Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rosuvastatin (AZD4522)Drug

    Also called Crestor

    Oral dose (od) 20 mg

  • PlaceboDrug

    Oral dose (od)

Study groups in NCT01164540
Study groupRoleWhat they receive
1ExperimentalOral Treatment
Receives: Drug: Rosuvastatin (AZD4522)
2Placebo comparatorOral treatment
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (2)

  1. All cause mortality

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

  2. 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 (VKA)" treatment period, with an estimated average "on (VKA) treatment period" of 6 months

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2010 (estimated)
  2. Study startFeb 2011
  3. Primary completionMar 2013 (estimated)
  4. Study completionMar 2013 (estimated)

Why it stopped: Due to discussion regarding the design of the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01164540
Sponsor's protocol ID
D3560L00093
Acronym
Du Lac
Status last verified
Dec 2010
First submitted
8 Jul 2010
Last updated
10 Dec 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin (AZD4522) in people with Venous Thrombosis and Pulmonary Embolism, run by AstraZeneca.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 10 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any event of venous thromboembolism (i.e. Deep Vein Thrombosis (DVT) and/or fatal or non-fatal Pulmonary Embolism(PE)) (time frame: Time to first occurrence in the overall treatment period, with a median treatment period of 9,5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01164540.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2010.

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