Acute Coronary Syndrome
Conditions
Brief summary
A prospective, randomised, open label study of 3 clinically licensed treatments for ACS to assess the effects of these treatments on blood tests of endogenous fibrinolysis. 50 patients will be randomised to each of the 3 treatment arms in 1:1:1 ratio. Patients will receive the randomised treatment for 1 month after their index admission with ACS.
Detailed description
Heart attacks are caused by a blood clot occurring in a blood vessel (artery) which supplies blood to the heart. Such a clot can build up and block the blood flow, depriving part of the heart muscle of oxygen and blood, causing transient or permanent damage to the heart muscle. The standard treatment for a heart attack is two blood thinning medications combined, every day, to reduce the risk of further blood clots forming and to prevent another heart attack. The highest risk of another heart attack is in the next 30 days after the first heart attack. However, despite two blood thinners combined, some patients still go on to have another clot (heart attack or stroke or death) and this can be life threatening. Earlier research has shown that through a blood test, it is possible to identify patients who remain at increased risk of further clots and who may benefit from further blood thinners to reduce the risk of further heart attack, stroke and death in the next 30 days. The aim of this study is to test which of 3 blood thinning treatment options (all already in widespread clinical use) is best for patients to reduce further blood clots, in particular the addition of low dose rivaroxaban.
Interventions
DRUGClopidogrel 75Mg Tablet
Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel
DRUGRivaroxaban 2.5Mg Tablet
Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel)
Prevention of atherothrombotic events in patients with acute coronary syndrome \[in combination with aspirin\]
Sponsors
University of Hertfordshire
East and North Hertfordshire NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female patients aged 18 years or over 2. Have a diagnosis of acute coronary syndrome requiring treatment with dual antiplatelet therapy 3. Be willing and able to understand the Participant Information Sheet and provide informed consent 4. Agree to comply with the drawing of blood samples for the assessments 5. Not meet any of the
Exclusion criteria
below
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 30 days | 30 days | To investigate, in patients with recent acute coronary syndrome and who have impaired endogenous fibrinolysis, whether the addition of low dose rivaroxaban to DAPT can improve endogenous thrombotic and fibrinolytic status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of further angioplasty | 6 months | Clinical events including re-intervention |
| Frequency of further heart attack, stroke or death | 6 months | Incidence of further major adverse cardiac events |
Countries
United Kingdom
Contacts
Primary ContactDiana A Gorog, MD, PhD, FRCP
Backup ContactYing X Gue, MBChB, MRCP
Outcome results
None listed