Clinical trial NCT02268773: 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
Official title: A Randomised, Two-period, Cross-over Trial to Compare the Effects of Acetylsalicylic Acid (75 mg/Day) With the Combination of Acetylsalicylic Acid (25 mg) + Modified-release Dipyridamole (200 mg) (bd) on Serum Thromboxane B2 Formation and Platelet Aggregation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-10-20
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

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

Primary outcomes:
measure: Absolute serum thromboxane B2 level
timeFrame: At day 3 after start of drug administration
Secondary outcomes:
measure: Change in platelet aggregation
timeFrame: At day 3 after start of drug administration
measure: Change in time course of inhibition of serum thromboxane B2
timeFrame: Pre-dose, up to day 14 after start of drug administration
measure: Change in time course of inhibition of platelet aggregation
timeFrame: Pre-dose, up to day 14 after start of drug administration
measure: Changes from baseline in vital signs
timeFrame: Pre-dose, up to 14 days after first drug administration
measure: Changes from baseline in laboratory tests
timeFrame: Pre-dose, up to 14 days after first drug administration
measure: Changes from baseline in physical examination
timeFrame: Pre-dose, up to 14 days after first drug administration
measure: Changes from baseline in 12-lead ECG
timeFrame: Pre-dose, up to 14 days after first drug administration
measure: Number of patients with adverse events
timeFrame: Up to 14 days after start of drug administration
Other outcomes:
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