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Angiomax

Phase 3

Cardiovascular Disease | Small molecule | Cardiovascular |Novartis AG|Last Updated: Nov 10, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment125

FDA Designations

No designations recorded

Clinical trial landscape

Angiomax · 2 trials · 3 indications

Phase 3 1Phase 2 1
NCT00079508Angiomax in Patients With HIT/HITTS Type II Undergoing CPBCardiovascular Disease
COMPLETED125 Analytics
PHASE3COMPLETED
Angiomax in Patients With HIT/HITTS Type II Undergoing CPB
Cardiovascular DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Primary Endpoint
7 days

In-hospital acute procedural success, defined as the absence of death, Q wave MI, repeat coronary revascularization, and stroke (hemorrhagic or ischemic) at hospital discharge or Day 7 after surgery ('Day 7/discharge'), whichever occurs first.

Observation of improvement for thrombosis or by clinical exam such as: Decrease in size of thrombus, restoration of flow through an occluded vessel, decrease in diameter of extremity or head.

Secondary Endpoints

In addition, efficacy will also be judged by demonstrating a decrease in the molecular markers of thrombin generation.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Angiomax (bivalirudin)DRUG250 mg vial administered as 1.0 mg/kg intravenous (IV) bolus and 2.5 mg/kg/h IV infusion during the procedure with the option to administer additional 0.1 to 0.5 mg/kg boluses to increase the level of anticoagulation as clinically indicated. A low-dose infusion could have been administered in the preoperative phase (up to 48 hours before the procedure) and in the postoperative phase (up to 14 days after the procedure) as clinically indicated for management of HIT/TS. A starting bolus of 0.1 mg/kg and/or an infusion of 0.2 mg/kg/h titrated to a desired activated partial thromboplastin time (aPTT), eg, 1.5-2.5 times baseline aPTT, was recommended.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria * Provide written informed consent before initiation of any study-related procedures, and * Be at least 18 years of age, and * Be scheduled for CABG, CABG single valve surgery, or isolated single valve surgery on CPB. Patients undergoing repeat (redo) CABG are also considered eli...

Countries:United States
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Frequently asked questions about Angiomax

What is Angiomax used for?

Angiomax is a small molecule cardiovascular drug being developed by Novartis AG for cardiovascular disease and thrombosis. It has been studied in patients with heparin-induced thrombocytopenia or heparin-induced thrombocytopenia with thrombosis syndrome type II undergoing coronary artery bypass surgery, as well as in infants under six months with thrombosis.

Who makes Angiomax?

Angiomax is being developed by Novartis AG, which is publicly traded under the ticker NVS. The drug is a small molecule therapeutic in the cardiovascular area.

What phase is Angiomax in?

Angiomax has completed Phase 3 clinical trials. It is an investigational drug and remains in clinical development, with no approval status indicated in the available trial data.

What clinical trials is Angiomax in?

Angiomax has been studied in two completed clinical trials. NCT00079508 was a Phase 3 study in patients with HIT or HITTS type II undergoing coronary artery bypass surgery, enrolling 125 participants. NCT00043277 was a Phase 2 study in infants under six months with thrombosis, enrolling 25 participants.

What does Angiomax target?

Angiomax is a small molecule drug, but its specific molecular target is not disclosed in the available information. It is being studied for its effects in cardiovascular disease and thrombosis, particularly in the context of heparin-induced thrombocytopenia.

Is Angiomax the same as bivalirudin?

Angiomax is the brand name for bivalirudin, a direct thrombin inhibitor. The drug is being developed by Novartis AG for use in cardiovascular procedures and thrombotic conditions.