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

NCT02741817 | Completed Phase 4

• 1 other identifier: STH 19177
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (3)

• Post-dose serum thromboxane B2, compared within-patients between the 2 dosing regimens by a paired t test.

  Approx 12 months from start date

• Post-dose urinary PGI-M, compared within-patients between the 2 dosing regimens by a paired t test.

  Approx 12 months from start date

• Ratio of post-dose serum TXB2:urinary PGI-M, compared within-patients between the 2 dosing regimens by a paired t test.

  Approx 12 months from start date

Secondary Outcomes (6)

• Pre-dose serum thromboxane B2, compared within-patients between the 2 dosing regimens by a paired t test.

  Approx 12 months from start date

• 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.

  Approx 12 months from start date

• 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.

  Approx 12 months from start date

• Post-dose bleeding time compared within-patients between the 2 dosing regimens by a paired t test.

  Approx 12 months from start date

• Ratio of pre-:post-dose serum TXB2, compared within-patients between the 2 dosing regimens by a paired t test.

  Approx 12 months from start date

Study Arms (2)

Aspirin 20mg

EXPERIMENTAL

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

Aspirin 75mg

EXPERIMENTAL

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

Interventions

Aspirin DRUG

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.

Aspirin 20mg; Aspirin 75mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S57AU, United Kingdom

Location

Related Publications (40)

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MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2016
• First Posted: April 18, 2016
• Study Start: June 26, 2016
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: March 17, 2021

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)