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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.

Is tirofiban and simvastatin the same as Aggrastat and Zocor?

Yes, tirofiban and simvastatin are the same as Aggrastat and Zocor, respectively. The Phase 3 clinical trial NCT00251576, titled 'Aggrastat to Zocor (AtoZ)', studied the use of these two approved drugs in patients who have experienced chest pain or a heart attack.