NCT00421538

Brief Summary

CACTUS-PTS is a randomized, placebo-controlled, double-blind study which aims primarily to determine the effectiveness of a 6 week course of therapeutic-dose LMWH (nadroparine) injections vs. placebo in patients with a first symptomatic isolated distal (calf) deep-vein thrombosis (IDDVT), as measured by rate of proximal DVT and symptomatic PE at 6 weeks. Additionally, the study aims to determine if the 6 week course of treatment with therapeutic-dose LMWH (nadroparine) injections, compared to placebo, decreases the frequency of post-thrombotic syndrome (PTS) at 1 year.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_3

Geographic Reach
3 countries

7 active sites

Status
completed

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

January 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2007

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

May 4, 2018

Status Verified

May 1, 2018

Enrollment Period

7.3 years

First QC Date

January 11, 2007

Last Update Submit

May 3, 2018

Conditions

Distal (Calf) Deep-vein Thrombosis

Keywords

Deep vein ThrombosisCalf vein thrombosisLow-molecular weight heparinPlaceboElastic contentionCompression Ultrasonography

Outcome Measures

Primary Outcomes (2)

  • Composite of rate of extension of distal DVT to proximal deep veins (includes ipsilateral extension or new contralateral proximal DVT) or symptomatic PE at 6 weeks

    6 weeks

  • Rate of post-thrombotic syndrome (PTS)

    Rate of post-thrombotic syndrome (PTS) diagnosed using the Villalta scale.

    1 year

Secondary Outcomes (6)

  • Individual components of the composite endpoint: distal DVT extension to proximal veins at 6 weeks and 90 days; PE at 6 weeks and 90 days

    6 weeks and 3 months

  • Major bleeding at 6 weeks and 90 days

    6 weeks and 3 months

  • Death at 6 weeks and 90 days

    6 weeks and 3 months

  • Serious adverse events at 6 weeks and 90 days

    6 weeks and 3 months

  • Generic and venous disease-specific Quality of Life scores

    1 year

  • +1 more secondary outcomes

Study Arms (2)

LMWH

ACTIVE COMPARATOR

Therapeutic dose of Nadroparin

Drug: nadroparine calcium

Placebo

PLACEBO COMPARATOR

Injectable placebo

Drug: Placebo

Interventions

nadroparine calciumDRUG

Once-daily injection of 171 U/Kg/day of nadroparine calcium for 6 weeks.

LMWH
PlaceboDRUG

Once-daily injectable placebo (sterilized NaCL 0.9%) for 6 weeks

Placebo

Eligibility Criteria

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

You may not qualify if:

  • Age less than 18 years
  • Previously objectively diagnosed DVT or PE
  • Distal DVT involving the tibioperoneal trunk (i.e. calf trifurcation)
  • Clinically suspected pulmonary embolism
  • Active cancer, receiving cancer treatment or cancer considered cured for \<6 months
  • Ipsilateral or contralateral proximal DVT
  • Indication for long-term anticoagulation (e.g. atrial fibrillation, mechanical heart valve...)
  • Pregnancy
  • Thrombocytopenia (platelet count \< 100 g/l)
  • Impaired renal function (serum creatinine \> 180 micromol/l or clearance to creatinine less than 30 ml/min)
  • Known hypersensitivity to heparin
  • Presence of an active bleeding or a pathology susceptible of bleeding in presence of anticoagulation (gastric ulcer, cerebral malignant disease...)
  • Treatment with daily NSAIDs (aspirin ≤160 mg/day permitted)
  • Body weight \>115 kg or \<40 kg
  • Treatment with therapeutic doses of anticoagulants for \>2 days, corresponding to: 2 injections of LMWH if once daily therapeutic LMWH used; 3 injections of LMWH if twice-daily therapeutic LMWH used; 1 dose of oral vitamin K antagonist (e.g. warfarin)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

Montpellier University Hospital

Montpellier, Languedoc, 34295, France

Location

University Hospital of Geneva

Geneva, Switzerland

Location

Related Publications (3)

  • Righini M, Robert-Ebadi H, Glauser F, Blondon M, Ouvry P, Diamand JM, Tissot A, Frappe P, Quere I, Kahn SR, Galanaud JP, Le Gal G. Effect of anticoagulant treatment on pain in distal deep vein thrombosis: an ancillary analysis from the cactus trial. J Thromb Haemost. 2019 Mar;17(3):507-510. doi: 10.1111/jth.14387. Epub 2019 Feb 3.

    PMID: 30656824DERIVED

  • Righini M, Galanaud JP, Guenneguez H, Brisot D, Diard A, Faisse P, Barrellier MT, Hamel-Desnos C, Jurus C, Pichot O, Martin M, Mazzolai L, Choquenet C, Accassat S, Robert-Ebadi H, Carrier M, Le Gal G, Mermilllod B, Laroche JP, Bounameaux H, Perrier A, Kahn SR, Quere I. Anticoagulant therapy for symptomatic calf deep vein thrombosis (CACTUS): a randomised, double-blind, placebo-controlled trial. Lancet Haematol. 2016 Dec;3(12):e556-e562. doi: 10.1016/S2352-3026(16)30131-4. Epub 2016 Nov 8.

    PMID: 27836513DERIVED

  • Guanella R, Righini M. Serial limited versus single complete compression ultrasonography for the diagnosis of lower extremity deep vein thrombosis. Semin Respir Crit Care Med. 2012 Apr;33(2):144-50. doi: 10.1055/s-0032-1311793. Epub 2012 May 30.

    PMID: 22648486DERIVED

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Nadroparin

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Marc Righini, MD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

  • Isabelle Quéré, MD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

  • Susan Kahn, MD

    Jewish General Hospital

    PRINCIPAL INVESTIGATOR

  • Marc Carrier, MD

    Ottawa Hospital

    PRINCIPAL INVESTIGATOR

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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2007

First Posted

January 12, 2007

Study Start

January 1, 2008

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

May 4, 2018

Record last verified: 2018-05

Locations

CH(1)FR(1)CA(5)