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AzTrials

ThromboembolismPhase 3NCT00038961

A Study to Evaluate the Efficacy and Safety of Fondaparinux Sodium When Used With Intermittent Pneumatic Compression to Prevent Venous Thromboembolic (IPC) Versus IPC Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdominal Surgery (APOLLO).

A Phase 3 study testing fondaparinux sodium in people with Thromboembolism, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicentre, randomized, double-blind, placebo controlled study. During this study all the patients will receive background venous thromboembolism (VTE) mechanical prophylaxis with intermittent pneumatic compression (IPC). Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Thromboembolism
What is being tested?
fondaparinux sodium
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,309 participants
Where
No sites listed yet
Study dates
Nov 2001to Oct 2004
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Undergoing abdominal surgery (any surgery between the diaphragm and pelvic floor) lasting longer than 45 minutes (duration from anesthesia induction to surgical closure)
  • Over 40 years of age
  • Subject who had signed the informed consent.

Who cannot join

  • Active, clinically significant bleeding
  • Documented congenital or acquired bleeding tendency/disorders
  • Active ulcerative gastrointestinal disease unless the reason for the present surgery.
  • Recent intracranial hemorrhage or recent (less than 3 months prior to randomisation) brain, spinal, or ophthalmologic surgery.
  • Indwelling intrathecal or epidural catheters for more than 6 hours after surgical closure.
  • Subjects who had a traumatic puncture or unusual difficulty in applying the catheter
Show all 28Show fewer
  • Known cerebral metastasis,
  • Subjects in whom hemostasis had not been established 6 hours after surgical closure,
  • Current thrombocytopenia,
  • Bacterial endocarditis
  • Creatinine level above 2.0 mg/dL (180 μmol/L) in a well-hydrated subject,
  • Documented hypersensitivity to contrast media,
  • Use of any contraindicated drug that could not be combined with the injection of contrast medium,
  • Patent with evidence of leg ischemia caused by peripheral vascular disease, unable to undergo IPC and unable to wear Elastic Stockings.
  • Mental disorders that could interfere with study participation and/or failure to give written informed consent to take part in the study,
  • Subject's life expectancy < 6 months,
  • Clinical sign of DVT and/or history of recent DVT,
  • Participation in any other therapeutic drug study or a device study evaluating DVT prophylaxis within 90 days preceding inclusion,
  • Previous participation in a study of fondaparinux sodium,
  • Known hypersensitivity to fondaparinux and its excipients,
  • Current addictive disorders that could interfere with study participation,
  • Administration of heparin, heparinoids, LMWH, oral anticoagulants, dextrans, hirudin, fibrinolytic agents or drugs blocking glycoprotein platelet receptors (GPIIb-IIIa) during the screening period, i.e., from admission to surgery,
  • Subjects for whom anticoagulant therapy was contraindicated or who had, due to concomitant disease, an indication for oral anticoagulant or heparins (including LMWH) and who could not discontinue those treatments,
  • Women of child-bearing potential: women not using an appropriate contraceptive method during the whole duration of study participation ,
  • Subject with body weight <50 kg,
  • Subjects, who in the opinion of the investigator, required a pharmacological prophylaxis in addition to intermittent pneumatic compression,
  • Known pregnancy and / or women who intended to breastfeed,
  • Subjects undergoing vascular surgery such as aorto-femoral bypass graft

About this study

Official title: A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subjects at Increased Risk Undergoing Major Abdomi

This is a multicentre, randomized, double-blind, placebo controlled study. During this study all the patients will receive background venous thromboembolism (VTE) mechanical prophylaxis with intermittent pneumatic compression (IPC).

Read the detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of fondaparinux in the prevention of venous thromboembolism (VTE) in subjects undergoing abdominal surgery at increased risk for VTE. During this study all subjects were to receive background VTE prophylaxis with intermittent pnuematic compression (IPC) ± elastic stockings (ES).

Screening Period ( Day -30-Day 0) all subjects at increased risk of VTE undergoing abdominal surgery and fulfilled the study entry criteria were eligible for the study.

Treatment Period (Day 7 ±2): At the baseline assessment on the day of surgery (Day 1) subjects who satisfied all inclusion/exclusion criteria were randomized (1:1) to receive either fondaparinux or placebo. All the subjects were to receive background therapy with IPC ±ES. The first administration of either fondaparinux 2.5mg or placebo was to take place 6 to 8 hours after surgical closure provided hemostasis was achieved. Thereafter a once daily subcutaneous injection of either fondaparinux 2.5mg or placebo was to be administered up to Day 7 ±2. During the treatment phase, subjects were assessed daily. A mandatory venogram was performed between Day 5 and 10 or earlier in the case of symptomatic VTE, but not more than 1 calendar day after the last study treatment administration.

Follow up Period (Day 30 ±2): A follow-up visit or contact was to take place at Day 30 ±2 days. Use of antithrombotic therapy for prevention of VTE after the mandatory venographyand during the entire Follow-up Period was left to the investigator's discretion.

Conditions
Thromboembolism
Being tested
fondaparinux sodium, placebo
Keywords
fondaparinux sodium, DVT Prevention, abdominal surgery, VTE prevention, venous thromboembolism, pulmonary embolism
Medical subject headings
Thromboembolism, Venous Thromboembolism, Pulmonary Embolism

What participants receive

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

  • fondaparinux sodiumDrug

    2.5 mg fondparinux sodium, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)

  • placeboOther

    placebo, daily, s.c. starting 6 to 8 hours after surgical closure for up to 7 +/- 2 days, administered on top of IPC +/- elastic stockings (ES)

Study groups in NCT00038961
Study groupRoleWhat they receive
Placebo + intermittent pneumatic compression (IPC)Placebo comparatorNot described
Receives: Other: placebo
fondaparinux + intermittent pneumatic compression (IPC)ExperimentalNot described
Receives: Drug: fondaparinux sodium

What is being measured

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

  1. venous thromboembolism (VTE)

    the incidence of VTE determined as any of the following VTE outcomes recorded up to the first venogram performed or up to Day 10, whichever occurred first: adjudicated manadatory veongram positive for DVT between Day 5 and Day 10; adjudicated symptomatic DVT and/or adjudicated non-fatal PE; adjudicated fatal PE

    Measured: adjudicated mandatory venogram positive for DVT between day 5 and day 10; up to day 10 for symptomatic DVT and/or adjudicated non fatal Pe , adjudicated fatal PE

  2. major bleeding

    adjudicated major bleeding

    Measured: first study drug injection to 2 days after last study drug injection and first study drug injection up to Day 32

Secondary outcomes (11)

  1. deep vein thrombosis (DVT)

    Incidence of any DVT, any proximal DVT, and distal only DVT

    Measured: up to Day 10

  2. symptomatic VTE (venous thromboembolism)

    Incidence of adjudicated symptomatic VTE (DVT, non fatal pulmonary embolism (PE), and fatal PE)

    Measured: up to Day 10 and up to Day 32

  3. initiation of curative treatment

    Initiation of curative treatment after VTE assessment used for the primary endpoint evaluation

    Measured: 3 years

  4. any VTE and all deaths

    incidence of any VTE and all deaths

    Measured: up to Day 10

  5. symptomatic VTE and all deaths

    incidence of adjudicated symptomatic VTE and all deaths

    Measured: up to Day 32

  6. minor bleeding

    adjudicated minor bleeding

    Measured: treatment period and up to day 32

  7. All major or minor bleeding

    All adjudicated (major or minor) bleeding

    Measured: 3 years

  8. Adverse events

    Adverse Events (AEs/serious adverse events (SAEs))

    Measured: 3 years

  9. Transfusion

    the need for transfusion and total blood units transfused

    Measured: 3 years

  10. Lab parameters

    changes from baseline in laboratory parameters

    Measured: 3 years

  11. Death

    Death

    Measured: 3 years

Timeline

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

  1. First posted10 Jun 2002 (estimated)
  2. Study startNov 2001
  3. Primary completionOct 2004
  4. Study completionOct 2004

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,309 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00038961
Sponsor's protocol ID
103414
Status last verified
Aug 2016
First submitted
5 Jun 2002
Last updated
1 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Turpie AG, Bauer KA, Caprini JA, Comp PC, Gent M, Muntz JE; Apollo Investigators. Fondaparinux combined with intermittent pneumatic compression vs. intermittent pneumatic compression alone for prevention of venous thromboembolism after abdominal surgery: a randomized, double-blind comparison. J Thromb Haemost. 2007 Sep;5(9):1854-61. doi: 10.1111/j.1538-7836.2007.02657.x.

    PubMed 17723125

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing fondaparinux sodium in people with Thromboembolism, run by GlaxoSmithKline.

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 3 inclusion and 28 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: finished, as of the sponsor's last update on 1 Sep 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

venous thromboembolism (VTE) (time frame: adjudicated mandatory venogram positive for DVT between day 5 and day 10; up to day 10 for symptomatic DVT and/or adjudicated non fatal Pe , adjudicated fatal PE). The study lists 2 primary outcomes in all. 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 NCT00038961, which also lists 1 linked publication.

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 1 Sep 2016.

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