NCT02327624

STEEL Percutaneous Coronary Intervention

Study of Two Regimens of TicagrElor Compared to Clopidogrel in Patients Undergoing ELective Percutaneous Coronary Intervention

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The principal hypothesis of this study is that two different maintenance regimens of ticagrelor are safe, tolerable and associated with significant inhibition of erythrocyte adenosine reuptake compared to clopidogrel in patients undergoing elective Percutaneous Coronary Intervention (PCI) for stable Coronary artery disease (CAD).

Detailed description

Coronary artery disease (CAD) is caused by fatty deposits building up over time in the arteries that supply the heart with blood, causing the arteries to narrow and reducing the amount of blood that can get to the heart. One of the treatment options for CAD is percutaneous coronary intervention (PCI) in which a balloon is inserted into the artery supplying the heart to open up the artery where it has narrowed. A stent is then left in the artery once the balloon is removed to hold the artery open and allow more blood to flow to the heart. One of the risks of this procedure, as in CAD itself, is the formation of blood clots that then block the arteries, stopping or reducing blood flow and causing a heart attack. Platelets are small blood cells involved in the formation of blood clots that cause heart attacks. Antiplatelet drugs (e.g. aspirin) are given to patients with CAD to reduce the risk of a clot forming in the future and causing a heart attack. In a recent large clinical trial (PLATO study), it was shown that heart attack patients treated with a new antiplatelet medication (ticagrelor) had fewer later heart attacks compared to the current standard treatment (clopidogrel). The STEELPCI study is comparing three different strategies for prescribing antiplatelet medication to patients with stable CAD who have a PCI. Patients on waiting list for PCI who meet the study inclusion/exclusion criteria will be invited to participate. Patients will have their PCI as normal but be randomised to take one of three different medication strategies, either clopidogrel or one of two doses of ticagrelor. Patient will take the medication for 30 days and have blood tests and meet with the research team during that time to assess the effects of each medication strategy.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Clopidogrel	Compare Clopidogrel to two doses of Ticagrelor 60 and 90
DRUG	Ticagrelor 60	Compare Clopidogrel to two doses of Ticagrelor 60 and 90
DRUG	Ticagrelor 90	Compare Clopidogrel to two doses of Ticagrelor 60 and 90

Timeline

• Start date: 2015-06-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2014-12-30
• Last updated: 2019-01-23

Locations

1 site across 1 country: United Kingdom