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Acetylsalicylic acid

Phase 2

Acute Coronary Syndrome | Small molecule | Cardiovascular |Johnson & Johnson|Last Updated: Dec 26, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment3,037

FDA Designations

No designations recorded

Clinical trial landscape

Acetylsalicylic acid · 1 trial · 1 indication

Phase 2 1
NCT02293395A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary SyndromeAcute Coronary Syndrome
COMPLETED3,037 Analytics
PHASE2COMPLETED
A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
Acute Coronary SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Non Coronary Artery Bypass Graft-Related (Non CABG-related) Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events
From start of study treatment until follow-up (up to 390 days)

Non CABG-related TIMI clinically significant bleeding events are sum of non CABG-related TIMI major bleeding events, TIMI minor bleeding events and TIMI bleeding events requiring medical attention. Major: any symptomatic intracranial bleeding: clinically overt signs of hemorrhage with hemoglobin (Hb) drop of greater than or equal to (\>=)5 gram per deciliter (g/dl) (or absolute drop in hematocrit of \>=15%) and fatal bleeding (results in death within 7 days); Minor: clinically overt sign of hemorrhage with Hb drop of 3 - \<5 g/dl (or drop in hematocrit of 9 - \<15%); requiring medical attention: bleeding event that required medical, surgical treatment/laboratory evaluation and did not meet criteria for major/minor bleeding event.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Stratum 1/ASAACTIVE_COMPARATORAcetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Stratum 1/RivaroxabanEXPERIMENTALRivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Stratum 2/ASAACTIVE_COMPARATORASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Stratum 2/RivaroxabanEXPERIMENTALRivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.

Interventions

NameTypeDescription
Acetylsalicylic acidDRUGASA 100 mg enteric-coated tablet once daily orally.
RivaroxabanDRUGRivaroxaban 2.5 mg tablet twice daily orally.
ClopidogrelDRUGClopidogrel 75 mg once daily orally.
TicagrelorDRUGTicagrelor 90 mg twice daily orally.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites259

Inclusion Criteria: * Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of: a) ST segment elevation m...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaCzechiaDenmarkFranceHungaryJapanNetherlandsPolandRussiaSouth KoreaSpainSwedenTurkey (Türkiye)Ukraine
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Frequently asked questions about Acetylsalicylic acid

What is Acetylsalicylic acid used for in Acute Coronary Syndrome?

Acetylsalicylic acid is a small molecule being studied for use in Acute Coronary Syndrome, a cardiovascular condition. It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in a clinical trial setting, and its safety and efficacy are being assessed in patients with this condition.

What does Acetylsalicylic acid target?

Acetylsalicylic acid is a small molecule being developed for Acute Coronary Syndrome. The specific molecular target of this drug has not been disclosed in the available information. It is being studied in a Phase 2 clinical trial to evaluate its safety and efficacy in patients with Acute Coronary Syndrome.

Who makes Acetylsalicylic acid?

Acetylsalicylic acid is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The drug is currently in Phase 2 clinical development for the treatment of Acute Coronary Syndrome, a cardiovascular condition.

What phase is Acetylsalicylic acid in?

Acetylsalicylic acid is in Phase 2 clinical development. It is an investigational drug being studied for Acute Coronary Syndrome. The drug has completed one Phase 2 clinical trial, and it is not yet approved by regulatory authorities. Further clinical development may be needed before it can be considered for approval.

What clinical trials is Acetylsalicylic acid in?

Acetylsalicylic acid has been studied in one clinical trial with the identifier NCT02293395. This Phase 2 trial, titled "A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome," has been completed. The trial enrolled 3,037 participants across multiple countries.

Is Acetylsalicylic acid the same as aspirin?

Acetylsalicylic acid is the chemical name for aspirin, a widely used medication. In the context of this clinical development program, Johnson & Johnson is studying acetylsalicylic acid as a treatment for Acute Coronary Syndrome. The drug is being evaluated in a Phase 2 clinical trial to assess its safety and efficacy in this patient population.