Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

Study Overview
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Brief Summary
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Prospective, single-center, double blind, double dummy, randomized trial. Platelet function tests and adenosine levels were assessed at baseline and 15 days after taking Ticagrelor with Prasugrel placebo or Prasugrel with Ticagrelor placebo in stable patients with coronary artery disease

Detailed Description
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This was a prospective, double blinded, randomized trial that compared platelet inhibition and adenosine levels with ticagrelor (180mg loading dose, followed by 90 mg BID) versus prasugrel (60mg loading dose, followed by 10 mg QD) . Patients were eligible if they were between 18 and 75 years old, were on aspirin without P2Y12 inhibitor at baseline and > 1 year after documented ACS. Platelet aggregation was compared with the Multiplate ADP® assay, performed at baseline and after 15 days on study medication. Adenosine plasma levels were measured with high performance liquid chromatography at the same time points

Official Title
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Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Prasugrel
* Drug: Ticagrelor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: between 18 and 75 years old were on aspirin without P2Y12 inhibitor at baseline > 1 year after documented acute coronary syndrome Exclusion Criteria: use of oral anticoagulation or P2Y12 at baseline Weight < 60kg History of tia or stroke Any coagulation disorders Refuse to sign the written consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prasugrel group<br>Prasugrel (60mg loading dose, followed by 10 mg QD for 15 days) + Ticagrelor placebo (Placebo loading dose followed by two pills a day) | Drug: Prasugrel<br>* Compared platelet inhibition and adenosine levels at baseline and after 15 days<br>Drug: Ticagrelor<br>* Compared platelet inhibition and adenosine levels at baseline and after 15 days<br>|
| Active Comparator: Ticagrelor group<br>Ticagrelor (180mg loading dose, followed by 90 mg BID) + Prasugrel placebo (Placebo loading dose followed by one pill a day) | Drug: Prasugrel<br>* Compared platelet inhibition and adenosine levels at baseline and after 15 days<br>Drug: Ticagrelor<br>* Compared platelet inhibition and adenosine levels at baseline and after 15 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare platelet inhibition between the two groups (ticagrelor and prasugrel) | Platelet aggregation was compared with the Multiplate ADP® assay at baseline and after 15 days on study medication | 15 days | 
| To compare adenosine levels between the two groups (ticagrelor and prasugrel) | Adenosine plasma levels were measured at baseline and after 15 days with high performance liquid chromatography at the same time points | 15 days |