Ignite Creation Date:
2024-05-06 @ 3:34 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02327624
Status:
COMPLETED
Last Update Posted:
2019-01-23
First Post:
2014-12-10
Brief Title:
STEEL Percutaneous Coronary Intervention
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Study of Two Regimens of TicagrElor Compared to Clopidogrel in Patients Undergoing ELective Percutaneous Coronary Intervention
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STEEL-PCI
Brief 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 eg 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 inclusionexclusion 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
Platelets are small blood cells involved in the formation of blood clots that cause heart attacks Antiplatelet drugs eg 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 inclusionexclusion 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None