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Trial record 19 of 1261 for:    ASPIRIN AND Platelet Aggregation

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

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ClinicalTrials.gov Identifier: NCT02268773
Recruitment Status : Completed
First Posted : October 20, 2014
Last Update Posted : October 20, 2014
Sponsor:
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 ]


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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02268773     History of Changes
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
Aspirin, Dipyridamole Drug Combination
Platelet Aggregation Inhibitors
Dipyridamole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Phosphodiesterase Inhibitors
Vasodilator Agents