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acetylsalicyclic acid

Phase 3

Acute Coronary Disease | Small molecule | Cardiovascular |Sanofi|Last Updated: Nov 18, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment25,086

FDA Designations

No designations recorded

Clinical trial landscape

acetylsalicyclic acid · 1 trial · 2 indications

Phase 3 1
NCT00335452Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionSAcute Coronary Disease
COMPLETED25,086 Analytics
PHASE3COMPLETED
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
Acute Coronary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison
30 days

The primary endpoint is the first occurrence of any of the following events: * Cardiovascular death (any death with a clear cardiovascular or unknown cause), * Myocardial Infarction (diagnosis of new Myocardial Infarction (MI) - nonfatal or fatal) * Stroke (presence of a new focal neurologic deficit thought to be vascular in origin, with signs or symptoms lasting more than 24 hours - nonfatal or fatal) reported between the randomization and Day 30 (inclusive), and validated by the blinded Event Adjudication Committee (EAC).

First Occurrence of CV Death / MI / Stroke - ASA Dose Comparison
30 days
First Occurrence of CV Death / MI / Stroke - Interaction Clopidogrel Treatment Regimen and ASA Dose Level
30 days
First Occurrence of CV Death / MI / Stroke - Clopidogrel Treatment Regimen Comparison in PCI Subgroup
30 days

Secondary Endpoints

Occurrence of Major Bleeding - Clopidogrel Dose Regimen Comparison
30 days
Occurrence of Major Bleeding - ASA Dose Level Comparison
30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Clopidogrel high dose treatment regimen + ASA high doseEXPERIMENTAL -
Clopidogrel high dose treatment regimen + ASA low doseEXPERIMENTAL -
Clopidogrel standard treatment regimen + ASA high doseACTIVE_COMPARATOR -
Clopidogrel standard treatment regimen + ASA low doseACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ClopidogrelDRUGoral administration
acetylsalicyclic acid (ASA)DRUGoral administration
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: * Diagnosed with acute coronary disease with clinical symptoms and at least electrocardiogram changes or cardiac enzymes elevated Exclusion Criteria: * Use of anticoagulants within 10 days with an international normalized ratio (INR) \> 1.5 or planned use during the hospitalis...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaCroatiaCzechiaEstoniaFinlandFranceGermanyGreeceIndiaIrelandIsraelItalyLatviaLithuaniaMalaysiaMexicoNetherlandsPolandRomaniaRussiaSingaporeSlovakiaSouth AfricaSouth KoreaSpainSwedenSwitzerlandTurkey (Türkiye)United Kingdom
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Frequently asked questions about acetylsalicyclic acid

What is acetylsalicylic acid used for in Acute Coronary Disease?

Acetylsalicylic acid is a small molecule being studied for use in Acute Coronary Disease, including unstable angina. It is currently in Phase 3 clinical development as an investigational therapy for this cardiovascular condition.

Who makes acetylsalicylic acid?

Sanofi (ticker: SNY) is the developer of acetylsalicylic acid. The company is conducting clinical research on this small molecule for the treatment of Acute Coronary Disease.

What phase is acetylsalicylic acid in?

Acetylsalicylic acid is in Phase 3 clinical development. It is an investigational drug for Acute Coronary Disease and has not been approved by regulatory authorities for this indication.

What clinical trials is acetylsalicylic acid in?

Acetylsalicylic acid has one completed Phase 3 trial, NCT00335452, titled "Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS." This randomized, double-blind, active-controlled study enrolled 25,086 participants with Acute Coronary Disease or unstable angina.

Is acetylsalicylic acid the same as aspirin?

Acetylsalicylic acid is the chemical name for aspirin. In the context of this clinical trial, it is being evaluated as an antiplatelet agent for patients with Acute Coronary Disease.