Effects of Acetylsalicylic Acid Compared With the Combination of Acetylsalicylic Acid + Modified-release Dipyridamole on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Asasantin®; Drug: Acetylsalicylic acid high dose; Drug: Acetylsalicylic acid low dose

• Registration Number: NCT02268773
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To compare the combination of acetylsalicylic acid (25 mg) + modified-release dipyridamole (200 mg) bd versus acetylsalicylic acid (75 mg dispersible tablet once daily) in its effect on inhibition of thromboxane B2 formation

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2000-05
• Status Verified: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-17
• Last Update Submitted: 2014-10-17
• Study First Posted: 2014-10-20
• Last Update Posted: 2014-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Male or female healthy volunteers aged 20 to 50 years
• Clinically normal medical history
• Clinically normal findings on physical examination
• Capable of comprehending and communicating effectively with the investigator and staff and of providing informed consent
• Willing to give informed consent prior to participation in the trial (i.e. prior to any trial-specific procedures)

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Exclusion Criteria

• Any clinically significant disease. (A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject's ability to participate in the study)
• Clinically significant abnormal baseline haematology, blood chemistry or urinalysis findings
• Serum glutamate-oxaloacetate transferase (SGOT) or serum glutamate-pyruvate transferase (SGPT) > 80 IU/L, bilirubin > 34 µmol/L or creatinine > 176 µmol/L regardless of clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
• Use of dipyridamole, aspirin or any non-steroidal anti-inflammatory agent (NSAID) during the previous two weeks
• Active peptic ulceration or history of peptic ulcer disease
• Known history of or suspected hypersensitivity to dipyridamole, aspirin, any NSAID or any other component of the test drugs
• History of any bleeding disorders
• History of cerebral haemorrhage
• Resting, seated blood pressure less than 90/60 mmHg
• Participation in any drug clinical trial within sixteen weeks prior to the start of the trial
• Any indication of current or previous abuse of alcohol, solvents or drugs
• Any chronic illness
• Asthma
• Requirement for any other medication one month before or during the study
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices or surgically sterile) were to be excluded
• Previous participation in the randomisation phase of this clinical trial

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acetylsalicylic acid low dose with Asasantin®	Asasantin®	-
Acetylsalicylic acid low dose with Asasantin®	Acetylsalicylic acid low dose	-
Acetylsalicylic acid high dose	Acetylsalicylic acid high dose	-

Primary Outcome Measures

Name	Time	Method
Absolute serum thromboxane B2 level	At day 3 after start of drug administration

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in physical examination	Pre-dose, up to 14 days after first drug administration
Change in platelet aggregation	At day 3 after start of drug administration	measured ex-vivo
Change in time course of inhibition of platelet aggregation	Pre-dose, up to day 14 after start of drug administration
Number of patients with adverse events	Up to 14 days after start of drug administration
Change in time course of inhibition of serum thromboxane B2	Pre-dose, up to day 14 after start of drug administration
Changes from baseline in vital signs	Pre-dose, up to 14 days after first drug administration	systolic and diastolic blood pressure, pulse rate
Changes from baseline in laboratory tests	Pre-dose, up to 14 days after first drug administration
Changes from baseline in 12-lead ECG	Pre-dose, up to 14 days after first drug administration