ActivePhase 2ACTRN12618001387213
A randomised double-blind placebo controlled trial of cardiovascular risk reduction during bereavement
Sponsor
Royal North Shore Hospital
Enrollment
80 participants
Start Date
Mar 10, 2011
Study Type
Interventional
Conditions
Summary
The purpose of the present project is to investigate whether individuals in early bereavement can reduce cardiovascular risk by taking therapy (beta-blocker and aspirin)
Eligibility
Sex: Both males and femalesMin Age: 18 Yearss
Inclusion Criteria1
- Spouses, partners or parents of patients who die in hospital; intensive care units, wards, emergency rooms, or are dead on arrival
Exclusion Criteria2
- Active malignancy or any severe illness, respiratory, heart, liver, renal failure, coagulopathy, thrombocytopenia, cognitive impairment, psychotic illness, immunosuppressive illness or taking immunosuppressive drugs, nursing home residents or cannot speak or read English. We will further exclude people taking beta blockers, heart rate lowering calcium channel blockers, aspirin or with resting systolic BP<120mmHg or heart rate <60bpm, or with contraindication to aspirin or beta blockers, including peptic ulcer, asthma, unstable diabetes mellitus, or known allergy to these drugs.
- Withdrawal: Subjects will be withdrawn at the project investigator's discretion, including if it is considered that participatiing in the study is causing undue psychological distress, or at the subjects request.
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Interventions
Active treatment: metoprolol 25mg and aspirin 100mg
Daily treatment for 6 weeks
Administered as one daily tablet each of metoprolol 25mg and aspirin 100mg or one tablet each of the corresponding p
Active treatment: metoprolol 25mg and aspirin 100mg Daily treatment for 6 weeks Administered as one daily tablet each of metoprolol 25mg and aspirin 100mg or one tablet each of the corresponding placebos. Adherence was monitored by drug table return.
Locations(5)
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ACTRN12618001387213
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