Ticagrelor and Adenosine

Radboud University Medical Center

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Ticagrelor 180 mg single dose

Study type: Interventional

Funder types: Other

Identifiers

NCT01996735

NL43379.091.13

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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14 participants in 2 patient groups, including a placebo group

Ticagrelor 180 mg single dose

Active Comparator group

Description:

Ticagrelor 180 mg single dose

Treatment:

Drug: Ticagrelor 180 mg single dose

Placebo

Placebo Comparator group

Description:

Placebo single dose

Treatment:

Drug: Placebo