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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Asasantin®; Drug: Acetylsalicylic acid low dose; Drug: Acetylsalicylic acid high dose

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Acetylsalicylic acid low dose with Asasantin®	Drug: Asasantin®; Other Names: modified-release dipyridamole; Drug: Acetylsalicylic acid low dose
ACTIVE_COMPARATOR: Acetylsalicylic acid high dose	Drug: Acetylsalicylic acid high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute serum thromboxane B2 level	At day 3 after start of drug administration

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: January 1, 2000
• Primary Completion (ACTUAL): May 1, 2000

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (ESTIMATE): October 20, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): October 20, 2014
• Last Update Submitted That Met QC Criteria: October 17, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Phosphodiesterase Inhibitors; Aspirin; Dipyridamole; Aspirin, Dipyridamole Drug Combination
• Other Study ID Numbers: 9.130