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A-Phase: tirofiban; Z-Phase simvastatin

Phase 3

Acute Coronary Syndrome | Small molecule | Cardiovascular |Organon & Co.|Last Updated: Aug 15, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment4,497

FDA Designations

No designations recorded

Clinical trial landscape

A-Phase: tirofiban; Z-Phase simvastatin · 1 trial · 1 indication

Phase 3 1
NCT00251576Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)Acute Coronary Syndrome
COMPLETED4,497 Analytics
PHASE3COMPLETED
Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)
Acute Coronary SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Z-Phase: combined frequency of the following clinical endpoint events: cardiovascular death, MI, readmission for ACS.

Secondary Endpoints

Z-Phase: the incidence of the following endpoints, evaluated individually and as a composite: cardiovascular death, MI, readmission for ACS, coronary revascularization due to documented ischemia and non-hemorrhagic stroke.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Interventions

NameTypeDescription
A-Phase: tirofiban; Z-Phase simvastatinDRUG -
Duration of Treatment: A-Phase: minimum suggested 48 hours, maximum suggested 108 hours. Z-Phase: 2 yearsDRUG -
Comparator: A-Phase: low molecular weight heparin, unfractionated heparinDRUG -
Duration of Treatment: A-Phase: low molecular weight heparin, 2 to 8 days; unfractionated heparin, minium suggested 48 hours, maximum 108 hoursDRUG -
Duration of Treatment: Z-Phase, 2 years.DRUG -
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * A-Phase: Chest pain at rest for 10 minutes, EKG changes or elevated cardiac blood work * Z-Phase: elevated cholesterol , plus at least one risk factor ( \> 70 years old, diabetes, history of prior heart or blood vessel disease, chest pain with EKG changes, elevation of cardiac...

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Frequently asked questions about A-Phase: tirofiban; Z-Phase simvastatin

What is tirofiban and simvastatin used for in Acute Coronary Syndrome?

Tirofiban and simvastatin are used in the treatment of Acute Coronary Syndrome, a condition that includes chest pain or heart attack. The combination was studied in a Phase 3 clinical trial to evaluate the use of two approved drugs in patients who have experienced these events.

Who makes tirofiban and simvastatin?

Tirofiban and simvastatin are being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company conducted a Phase 3 clinical trial to study the use of these two drugs in patients with Acute Coronary Syndrome.

What phase is tirofiban and simvastatin in?

Tirofiban and simvastatin are in Phase 3 clinical development for Acute Coronary Syndrome. The Phase 3 trial, which has been completed, enrolled 4,497 patients and was designed to evaluate the use of these two approved drugs in patients who have experienced chest pain or a heart attack.

What clinical trials is tirofiban and simvastatin in?

Tirofiban and simvastatin were studied in a Phase 3 clinical trial registered as NCT00251576, titled 'Aggrastat to Zocor (AtoZ) - the Use of Two Approved Drugs to Treat Patients Who Have Experienced Chest Pain or a Heart Attack (0733-180)'. This trial, which has been completed, enrolled 4,497 patients with Acute Coronary Syndrome.