NCT04508855

Brief Summary

The primary objective is to assess the safety and efficacy of switching from direct oral anticoagulants to low molecular weight heparin in cancer patients during antineoplastic therapy

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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withdrawn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

Study Start

First participant enrolled

August 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

August 8, 2020

Last Update Submit

July 29, 2024

Conditions

CancerAtrial Fibrillation

Keywords

CancerAnticoagulationAtrial fibrillationDirect oral anticoagulantslow molecular weight heparin

Outcome Measures

Primary Outcomes (2)

  • Major bleeding

    Death or a decrease in hemoglobin level of ≥ 2 g/dL over 24 hours or the need for transfusion of ≥ 2 units of packed red cells or clinically overt bleeding at critical site (eg, intracranial, retroperitoneal)

    6 months

  • Clinical relevant bleeding

    Bleeding that does not meet the criteria for major bleeding, however, it requires medical treatment or it affects the patient's daily activity

    6 months

Secondary Outcomes (2)

  • Deep vein thrombosis or pulmonary embolism

    6 months

  • Thromboembolic stroke or systemic embolism

    6 months

Study Arms (1)

Cancer patients with atrial fibrillation

All patients will be assigned to receive subcutaneous LMWH in therapeutic doses More specifically the regimens will be as follows: Tinzaparin 175 units/Kg once daily; Enoxaparin 1unit/kg twice daily; Fondaparinux \<50 kg, 5 mg SC once daily, 50-100 kg, 7.5 mg SC once daily, \>100 kg, 10 mg SC once daily; Bemiparin 115 IU/kg once daily; \<50kg, 5000IU, 50-70kg, 7.500 IU, \>70kg, 10000IU Nadroparin: Patients weighing 40 to 100 kg: SC, 171 anti-factor Xa IU per kg of body weight once a day; patients weighing over 100 kg will not receive nadroparin because a treatment dosage has not been established; Dalteparin: 200 units IU/kg SC daily for 30 days, then 150 units IU/Kg SC daily Dose adjustments will occur only in case of renal insufficiency according to the medicine's SPC The treatment with the LMWH will last at least during the period of active antineoplastic therapy of cancer patients

Drug: Low molecular weight heparin

Interventions

Low molecular weight heparinDRUG

Switch from direct oral anticoagulants to low molecular weight heparin

Cancer patients with atrial fibrillation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with cancer and atrial fibrillation receiving direct oral anticoagulants and antineoplastic therapy

You may qualify if:

  • Subjects diagnosed with cancer other than basal-cell or squamous-cell skin cancer which was objectively confirmed and are programmed for antineoplastic treatment
  • Subjects receiving direct oral anticoagulant treatment (rivaroxaban, dabigatran, apixaban, edoxaban) for prevention of stroke and systemic embolism in non-valvular atrial fibrillation

You may not qualify if:

  • Patients that have active or serious bleeding within the previous two weeks
  • Patients that have conditions associated with high bleeding risk (active peptic ulcer, recent neurosurgery
  • Patients with platelet count below 50000 per cubic millimeter
  • Patients who have contraindications to heparin (heparin-induced thrombocytopenia)
  • Patients with calculated creatinine clearance \< 30 ml/min using the Cockcroft-Gault formula
  • Women who are pregnant
  • Life expectancy less than 6 months
  • Anticoagulation contraindications
  • Recent brain surgery within 6 months
  • Vascular surgery within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AHEPA University Hospital

Thessaloniki, 54636, Greece

Location

Theagenio Cancer Hospital

Thessaloniki, Greece

Location

Related Publications (5)

  • Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available.

    PMID: 22922413BACKGROUND

  • Hu YF, Liu CJ, Chang PM, Tsao HM, Lin YJ, Chang SL, Lo LW, Tuan TC, Li CH, Chao TF, Chung FP, Liao JN, Chen TJ, Chen SA. Incident thromboembolism and heart failure associated with new-onset atrial fibrillation in cancer patients. Int J Cardiol. 2013 May 10;165(2):355-7. doi: 10.1016/j.ijcard.2012.08.036. Epub 2012 Sep 16. No abstract available.

    PMID: 22989607BACKGROUND

  • Lee AY, Levine MN, Baker RI, Bowden C, Kakkar AK, Prins M, Rickles FR, Julian JA, Haley S, Kovacs MJ, Gent M; Randomized Comparison of Low-Molecular-Weight Heparin versus Oral Anticoagulant Therapy for the Prevention of Recurrent Venous Thromboembolism in Patients with Cancer (CLOT) Investigators. Low-molecular-weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. N Engl J Med. 2003 Jul 10;349(2):146-53. doi: 10.1056/NEJMoa025313.

    PMID: 12853587BACKGROUND

  • Young AM, Marshall A, Thirlwall J, Chapman O, Lokare A, Hill C, Hale D, Dunn JA, Lyman GH, Hutchinson C, MacCallum P, Kakkar A, Hobbs FDR, Petrou S, Dale J, Poole CJ, Maraveyas A, Levine M. Comparison of an Oral Factor Xa Inhibitor With Low Molecular Weight Heparin in Patients With Cancer With Venous Thromboembolism: Results of a Randomized Trial (SELECT-D). J Clin Oncol. 2018 Jul 10;36(20):2017-2023. doi: 10.1200/JCO.2018.78.8034. Epub 2018 May 10.

    PMID: 29746227BACKGROUND

  • Raskob GE, van Es N, Verhamme P, Carrier M, Di Nisio M, Garcia D, Grosso MA, Kakkar AK, Kovacs MJ, Mercuri MF, Meyer G, Segers A, Shi M, Wang TF, Yeo E, Zhang G, Zwicker JI, Weitz JI, Buller HR; Hokusai VTE Cancer Investigators. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624. doi: 10.1056/NEJMoa1711948. Epub 2017 Dec 12.

    PMID: 29231094BACKGROUND

MeSH Terms

Conditions

NeoplasmsAtrial Fibrillation

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Cardiology

Study Record Dates

First Submitted

August 8, 2020

First Posted

August 11, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

July 30, 2024

Record last verified: 2024-07

Locations

GR(2)