Trial Summary
1. INTRODUCTION
• The CLARITY Trial aims to work out which tablet(s) are best at preventing complications of blocked arteries after undergoing angioplasty, which is a medical procedure used to widen narrowed or blocked arteries using a balloon or stent.
• After an angioplasty, most patients are given medications designed to prevent blood clots. These are called “blood thinners”. They help keep the arteries open and lower the chance of needing an amputation.
• There are many types of blood thinners. Sometimes, two types of blood thinners are used together. However, the optimal treatment after leg angioplasty has not been systematically studied before.
• The CLARITY Trial aims to work out which tablet(s) are best at preventing complications of blocked arteries after undergoing angioplasty, which is a medical procedure used to widen narrowed or blocked arteries using a balloon or stent.
• After an angioplasty, most patients are given medications designed to prevent blood clots. These are called “blood thinners”. They help keep the arteries open and lower the chance of needing an amputation.
• There are many types of blood thinners. Sometimes, two types of blood thinners are used together. However, the optimal treatment after leg angioplasty has not been systematically studied before.
2. AIM OF THE RESEARCH• The CLARITY Trial compares three different commonly used blood-thinner treatments to see if a certain tablet or combination of tablets leads to better health after angioplasty.
• Participating in the trial will help us find out which blood-thinner treatment is better at preventing health problems in patients such as blocked leg arteries, leg loss (amputation), heart attacks, strokes, serious bleeding (bleeding into the body such as brain, stomach or bowel, or needing admission to hospital because of bleeding), and other health outcomes. |
3. WHAT PARTICIPATION INVOLVES• The CLARITY Trial will last for approximately 3 years. If you volunteer to take part, your participation will last between 1 to 3 years, depending on when you join the trial.
• You will be chosen at random (by a computer) to receive either clopidogrel alone, aspirin and clopidogrel, or aspirin and rivaroxaban. You will be asked to:
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4. THE QUESTIONNAIRES and FOLLOW-UP
We will look at:
- Wellbeing and daily activities, and healthcare use.
- You will be contacted by the research team to complete the questionnaires at the start, 2 months, 6 months, and once a year after your angioplasty procedure (for the duration of the trial).
• You will not be required to attend any additional in-person monitoring sessions or appointments as part of the trial. • You will only need to attend routine follow-up appointments with your medical team.
• Your medical team will monitor your safety and well-being throughout the trial.
- Wellbeing and daily activities, and healthcare use.
- You will be contacted by the research team to complete the questionnaires at the start, 2 months, 6 months, and once a year after your angioplasty procedure (for the duration of the trial).
• You will not be required to attend any additional in-person monitoring sessions or appointments as part of the trial. • You will only need to attend routine follow-up appointments with your medical team.
• Your medical team will monitor your safety and well-being throughout the trial.
