A Study of the Onset and Offset of Antiplatelet Effects Comparing Ticagrelor, Clopidogrel, and Placebo With Aspirin

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Coronary Artery Disease

Treatments: Drug: Ticagrelor Tablets; Drug: Aspirin Tablets; Drug: Clopidogrel (over encapsulated) capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528411

D5130C00048

Details and patient eligibility

About

The purpose of this study is to see how Ticagrelor, a new oral reversible anti-platelet medication, affects platelets. Anti-platelet agents are medications that block the formation of blood clots by preventing the clumping of platelets. Blood clots prevent us from bleeding, but when they form inside the arteries their formation is linked to a risk of medical problems such as heart attack and stroke. This study investigated how long it takes for Ticagrelor to begin working and how long it takes for it to stop working after the last dose of drug. Ticagrelor will be compared to clopidogrel, an established anti-platelet treatment for preventing blood clots, and placebo plus Aspirin.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented stable Coronary Artery Disease (stable angina, previous MI history, previous history of revascularization);
• Females of child bearing potential must have a negative pregnancy test prior to receiving study drug and be willing to use a hormonal contraceptive in addition to double barrier contraception

Exclusion criteria

• History of Acute Coronary Syndromes within 12 months of screening or need for revascularization (angioplasty or Coronary Artery Bypass Graft (CABG))
• History of liver or kidney disease
• Have increased bleeding risk, eg, recent gastrointestinal bleed, uncontrolled high blood pressure, low platelet count, recent major trauma
• History of intolerance or allergy to Aspirin or clopidogrel

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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123 participants in 3 patient groups

1

Active Comparator group

Description:

Aspirin + Placebo

Treatment:

Drug: Aspirin Tablets

2

Active Comparator group

Description:

Aspirin + clopidogrel

Treatment:

Drug: Clopidogrel (over encapsulated) capsule

Drug: Aspirin Tablets

3

Experimental group

Description:

Aspirin + Ticagrelor

Treatment:

Drug: Aspirin Tablets

Drug: Ticagrelor Tablets