WithdrawnPhase 2ACTRN12613000826741

Pilot trial of Aspirin versus Ticagrelor in Congestive Heart Failure

Sponsor

St Vincent's Hospital, Heart Failure Research Trust Fund #869883

Enrollment

30 participants

Start Date

Jul 29, 2013

Study Type

Interventional

Conditions

Congestive Heart failure patients Heart Failure

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Inclusion Criteria6

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 Criteria8

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

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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

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.