None listed
Conditions
Brief summary
The purpose of this trial is to investigate whether Aspirin and Ticagrelor have different effects on blood vessel and heart function in the setting of heart failure.
Interventions
This is a prospective, randomised, double-blind cross-over study of 30 heart failure patients on aspirin. They will have aspirin (oral) stopped for 4 weeks and then be randomised to 2 groups. Group 1 will be aspirin (orally 100mg) and placebo for 6 weeks and then a 4 week no drug and then Ticagrelor (orally) for 6 weeks. Group 2: will be on Ticagrelor for 6 weeks, no drug for 4 weeks, and then aspirin and placebo (bd for 6 weeks. The patients will be followed up for 20 weeks.
Group 1 patients
This is a prospective, randomised, double-blind cross-over study of 30 heart failure patients on aspirin. They will have aspirin (oral) stopped for 4 weeks and then be randomised to 2 groups. Group 1 will be aspirin (orally 100mg) and placebo for 6 weeks and then a 4 week no drug and then Ticagrelor (orally) for 6 weeks. Group 2: will be on Ticagrelor for 6 weeks, no drug for 4 weeks, and then aspirin and placebo (bd for 6 weeks. The patients will be followed up for 20 weeks. Group 1 patients will be treated with aspirin and placebo bd (twice a day) for 6 weeks.Group 2 patients Ticagrelor 90 mg bd for 6 weeks and then cross over. For monitoring this trial in regards to adherance. The patients will be followed up by the Trial Co-ordinator and Principal Investigator at the followup visits. The drugs will be dispensed by pharmacy at each visit. The patients will be screened and adverse events and compliance will be sought at each visit and and electrolytes and BNP checked at at all visits as well.
Sponsors
St Vincent's Hospital, Heart Failure Research Trust Fund #869883
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
-Men or women age greater than 18 years of age -on aspirin and ACE inhibitor -symptomatic heart failure with stable therapy -Serum pro-BNP greater than 600 pg/mLor NT pro BNP greater than 400 pg/mL and Heart Failure -ongoing treatment with diuretics -informed consent
Exclusion criteria
-aspirin contraindicated or ticagrelor -Heart failure due to a reversible cause -ongoing indication to continue aspirin or other antiplatelet therapy -Atrial fibrillation -Unstable heart failure or treatment regime -life limiting systemic illness -conditions that might interfere with protocol compliance] -Patients taking NSAID's, clopidogrel, Prasugrel, cyclosporin, or simvastin and ongoing CYP3A4 inhibitors
Outcome results
None listed