Ticagrelor and Adenosine

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Ticagrelor 180 mg single dose; Drug: Placebo

• Registration Number: NCT01996735
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Preclinical studies have shown that the P2Y12 receptor antagonist ticagrelor can increase the extracellular concentration of the endogenous nucleoside adenosine by inhibiting the cellular uptake of adenosine via the equilibrative nucleoside transporter (ENT). This mechanism can contribute to the beneficial effects and to the side effects (dyspnea) of ticagrelor in patients with an acute myocardial infarction. In the current research proposal, we aim to investigate whether ticagrelor increases adenosine receptor stimulation in humans in vivo by ENT inhibition.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-02
• Study Start: 2013-04
• Study First Submitted: 2013-04-26
• Primary Completion: 2013-11
• Study First Submitted QC: 2013-11-21
• Study First Posted: 2013-11-27
• Study Completion: 2013-12
• Last Update Submitted: 2014-01-09
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

• Male sex
• Age 18-40 years
• Healthy
• Written informed consent

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Exclusion Criteria

• Smoking
• Hypertension (Blood pressure >140 mmHg and/or >90 mmHg - SBP/DBP-)
• Diabetes Mellitus (fasting glucose > 7.0 mmol/L or random > 11.0 mmol/L)
• History of any cardiovascular disease
• History of chronic obstructive pulmonary disease (COPD) or asthma
• Bleeding tendency
• Concomitant use of medication
• Renal dysfunction (MDRD < 60 ml/min)
• Liver enzyme abnormalities (ALAT > twice upper limit of normality)
• Thrombocytopenia (<150*109/ml)
• Second/third degree AV-block on electrocardiography

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ticagrelor 180 mg single dose	Ticagrelor 180 mg single dose	Ticagrelor 180 mg single dose
Placebo	Placebo	Placebo single dose

Primary Outcome Measures

Name	Time	Method
Forearm blood flow response	Directly after 2 and 5 minutes of forearm ischemia	Directly after 2 and 5 minutes of forearm ischemia.The forearm blood flow will be measured by plethysmography.

Secondary Outcome Measures

Name	Time	Method
Forearm blood flow respons	Directly after administration of dipyridamole	Forearm blood flow response to the intrabrachial administration of incremental dosages of dipyridamole, after treatment with ticagrelor compared to placebo. The forearm blood flow will be measured by plethysmography
ex-vivo adenosine uptake in isolated erythrocytes	2 hours after intake of studymedication	To study whether ticagrelor inhibits the ex-vivo adenosine uptake in isolated erythrocytes

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands