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Trial record 38 of 85 for:    ASPIRIN AND thromboxane

WilL LOWer Dose Aspirin be More Effective Following ACS? (WILLOW - ACS) (WILLOW ACS)

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ClinicalTrials.gov Identifier: NCT02741817
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:
The study is going to compare two different doses of aspirin for the treatment of heart disease in combination with the anticlotting medication ticagrelor. One of these doses of aspirin, 75 milligrams (mg) once a day, is the current standard treatment dose of aspirin used to treat heart attacks and angina. The other, 20 mg twice a day, is lower than the standard but there is growing scientific evidence that, when given with ticagrelor, this might offer advantages over the usual dose.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Aspirin Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: WilL LOWer Dose Aspirin be More Effective Following ACS? (WILLOW - ACS)
Actual Study Start Date : June 26, 2016
Actual Primary Completion Date : April 7, 2017
Actual Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin 20mg
Supplied with sachets of 100mg soluble aspirin and training, instructions and equipment will be provided to prepare 20 mg dose twice daily x14 then aspirin 75mg once daily x14
Drug: Aspirin
The intervention has been described previously in both arms individually. Group A will receive 20mg of soluble Aspirin and group B with 75mg of soluble Aspirin. As this is a crossover study, all patients will fall under both groups throughout the duration and be un-blinded.

Experimental: Aspirin 75mg
This is the standard dose of aspirin the participant will already be taking. The study will require the participants to switch to soluble aspirin for two weeks to enable accurate comparison with the other dose and to take their aspirin dose in the morning. Participants will be provided with a supply of soluble aspirin, along with training, instructions and equipment to help prepare it. They should not take their usual aspirin tablets whilst receiving the study medication, but should continue all other usual medications.
Drug: Aspirin
The intervention has been described previously in both arms individually. Group A will receive 20mg of soluble Aspirin and group B with 75mg of soluble Aspirin. As this is a crossover study, all patients will fall under both groups throughout the duration and be un-blinded.




Primary Outcome Measures :
  1. Post-dose serum thromboxane B2, compared within-patients between the 2 dosing regimens by a paired t test. [ Time Frame: Approx 12 months from start date ]
  2. Post-dose urinary PGI-M, compared within-patients between the 2 dosing regimens by a paired t test. [ Time Frame: Approx 12 months from start date ]
  3. Ratio of post-dose serum TXB2:urinary PGI-M, compared within-patients between the 2 dosing regimens by a paired t test. [ Time Frame: Approx 12 months from start date ]

Secondary Outcome Measures :
  1. Pre-dose serum thromboxane B2, compared within-patients between the 2 dosing regimens by a paired t test. [ Time Frame: Approx 12 months from start date ]
  2. Maximum and final post-dose platelet aggregation induced by 0.1, 0.3 and 1 mM arachidonic acid; 1, 4 and 16 µg/ml collagen; and 20 µM ADP compared within-patients between the 2 dosing regimens by paired t tests. [ Time Frame: Approx 12 months from start date ]
  3. Maximum and final pre-dose platelet aggregation induced by 0.1, 0.3 and 1 mM arachidonic acid; 1, 4 and 16 µg/ml collagen; and 20 µM ADP compared within-patients between the 2 dosing regimens by paired t tests. [ Time Frame: Approx 12 months from start date ]
  4. Post-dose bleeding time compared within-patients between the 2 dosing regimens by a paired t test. [ Time Frame: Approx 12 months from start date ]
  5. Ratio of pre-:post-dose serum TXB2, compared within-patients between the 2 dosing regimens by a paired t test. [ Time Frame: Approx 12 months from start date ]
  6. Ratio of pre-:post-dose maximum and final platelet aggregation induced by 0.1, 0.3 and 1 mM arachidonic acid; 1, 4 and 16 µg/ml collagen; and 20 µM ADP compared within-patients between the 2 dosing regimens by paired t tests. [ Time Frame: Approx 12 months from start date ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For inclusion in the study, subjects should fulfill the following criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Male or female aged greater than 18 years
  3. Previous diagnosis of acute coronary syndrome greater than 30 days and less than 10 months before enrollment
  4. Receiving dual antiplatelet therapy with aspirin 75 mg once daily and ticagrelor 90 mg twice daily

Exclusion Criteria:

Subjects should not enter the study if any of the following exclusion criteria are fulfilled:

  1. Presence of an indication for dual antiplatelet therapy other than ischaemic heart disease
  2. PCI with drug eluting or bare metal stent(s) within 30 days of randomization
  3. Any history of stent implantation to the left main coronary artery
  4. Any history of stent thrombosis during dual antiplatelet therapy
  5. Planned procedure for coronary revascularization
  6. Any planned surgery or other procedure that may require suspension or discontinuation of dual antiplatelet therapy expected to occur within 3 months of randomisation
  7. Prior intention by patient or physician to discontinue aspirin and/or ticagrelor within the study period
  8. Receiving doses of aspirin and ticagrelor other than 75 mg once daily and 90mg twice daily respectively

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741817


Locations
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United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S57AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

Publications:

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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02741817     History of Changes
Other Study ID Numbers: STH 19177
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: April 25, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Aspirin
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
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
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics