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Trial record 4 of 88 for:    ASPIRIN AND thromboxane

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02268773
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Healthy Drug: Asasantin® Drug: Acetylsalicylic acid low dose Drug: Acetylsalicylic acid high dose Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2000
Actual Primary Completion Date : May 2000

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Acetylsalicylic acid low dose with Asasantin® Drug: Asasantin®
Other Name: modified-release dipyridamole

Drug: Acetylsalicylic acid low dose
Active Comparator: Acetylsalicylic acid high dose Drug: Acetylsalicylic acid high dose

Primary Outcome Measures :
  1. Absolute serum thromboxane B2 level [ Time Frame: At day 3 after start of drug administration ]

Secondary Outcome Measures :
  1. Change in platelet aggregation [ Time Frame: At day 3 after start of drug administration ]
    measured ex-vivo

  2. Change in time course of inhibition of serum thromboxane B2 [ Time Frame: Pre-dose, up to day 14 after start of drug administration ]
  3. Change in time course of inhibition of platelet aggregation [ Time Frame: Pre-dose, up to day 14 after start of drug administration ]
  4. Changes from baseline in vital signs [ Time Frame: Pre-dose, up to 14 days after first drug administration ]
    systolic and diastolic blood pressure, pulse rate

  5. Changes from baseline in laboratory tests [ Time Frame: Pre-dose, up to 14 days after first drug administration ]
  6. Changes from baseline in physical examination [ Time Frame: Pre-dose, up to 14 days after first drug administration ]
  7. Changes from baseline in 12-lead ECG [ Time Frame: Pre-dose, up to 14 days after first drug administration ]
  8. Number of patients with adverse events [ Time Frame: Up to 14 days after start of drug administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02268773    
Other Study ID Numbers: 9.130
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: October 20, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Aspirin, Dipyridamole Drug Combination
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Phosphodiesterase Inhibitors
Vasodilator Agents