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UFH

Phase 2

Cardiovascular Disease | Small molecule | Cardiovascular |Bayer AG|Last Updated: Jun 23, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

UFH · 1 trial · 2 indications

Phase 2 1
NCT01442792Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary InterventionCardiovascular Disease
COMPLETED108 Analytics
PHASE2COMPLETED
Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention
Cardiovascular DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The percentage of subjects who require bail-out anticoagulant therapy in the context of an ischemic coronary event
During the index Percutaneous Coronary Intervention procedure
The percentage of subjects who experience an angiographic flow limiting thrombotic event
During the index Percutaneous Coronary Intervention procedure
The percentage of subjects who experience thrombus formation on the Percutaneous Coronary Intervention equipment
During the index Percutaneous Coronary Intervention procedure
The percentage of subjects who experience an Myocardial Infarction due to the Percutaneous Coronary Intervention equipment procedure
During the index Percutaneous Coronary Intervention procedure

Secondary Endpoints

Bleeding (Thrombolysis in Myocardial Infarction major, minor and Bleeding academic research consortium type 2, 3 and 5)
Up to 30 days post index Percutaneous coronary intervention procedure
Composite of clinical ischemic events (all death, non-fatal Myocardial Infarction, non-fatal stroke and target lesion revascularization
Up to 30 days post index Percutaneous coronary intervention procedure
Coagulation profile of Rivaroxaban (Activated Partial Thromboplastin Time)
1 to 5 days prior percutaneous coronary intervention (PCI) and the day of PCI (from 2-4 h pre PCI until 48h post PCI or discharge of patient if earlier)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Arm 1ACTIVE_COMPARATOR -
Arm 2EXPERIMENTAL -
Arm 3EXPERIMENTAL -
Arm 4EXPERIMENTAL -

Interventions

NameTypeDescription
UFHDRUGUnfractionated Heparin: 70-100 IU/Kg bolus and adjusted upon activated coagulation time (ACT) 250 300 seconds
Rivaroxaban (Xarelto, BAY59-7939)DRUG10 mg single dose Rivaroxaban (per os)
Rivaroxaban (Xarelto, BAY59-7939) and UFHDRUG10 mg single dose Rivaroxaban (per os) followed by bolus 50 IU/Kg unfractionated heparin (UFH)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Male or female subject aged 18 years or more with no upper age limit and willing to comply with the protocol * Symptomatic coronary artery disease due to undergo an elective (non-emergent) Percutaneous Coronary Intervention (PCI) on one or two lesions in the native coronary ve...

Countries:BelgiumNetherlands
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Frequently asked questions about UFH

What is UFH?

UFH is an investigational small molecule being developed by Bayer AG for cardiovascular disease. It is currently in Phase 2 clinical development. UFH is being studied for its potential role in treating conditions related to cardiovascular disease, including coronary artery disease.

What is UFH used for in cardiovascular disease?

UFH is being investigated for use in cardiovascular disease, specifically in the context of elective percutaneous coronary intervention. A Phase 2 clinical trial explored its efficacy and safety in patients with cardiovascular disease and coronary artery disease, with the aim of supporting the procedure.

Who makes UFH?

UFH is being developed by Bayer AG, a pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY. The company is conducting clinical research to evaluate UFH as a potential treatment for cardiovascular disease.

What phase is UFH in?

UFH is in Phase 2 clinical development. It has completed one Phase 2 trial, which was an active-controlled, randomized study. The drug is still investigational and has not yet been approved for any use.

What clinical trials is UFH in?

UFH has been studied in one clinical trial, identified as NCT01442792. This Phase 2 trial, titled 'Exploring the Efficacy and Safety of Rivaroxaban to Support Elective Percutaneous Coronary Intervention,' was completed and enrolled 108 participants with cardiovascular disease and coronary artery disease.

Is UFH the same as rivaroxaban?

UFH is not the same as rivaroxaban. The clinical trial NCT01442792, which studied UFH, was titled with a reference to rivaroxaban, but UFH is a distinct investigational drug. The trial compared UFH against an active control, but the specific identity of UFH is separate from rivaroxaban.