Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02169596
Status:
COMPLETED
Last Update Posted:
2019-07-15
First Post:
2014-06-17
Brief Title:
Is Efficacy of PLAtelet Aggregation Inhibition by Ticagrelor Mediated P2Y12 Blockade Dependent Upon Endogenous Endothelial Nitric OXide
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Hull University Teaching Hospitals NHS Trust
Study Overview
Official Title:
a Single Centre Open Pilot Study to Explore if the Efficacy of PLAtelet Aggregation Inhibition by Ticagrelor Mediated P2Y12 Blockade Dependent Upon Endogenous Endothelial Nitric OXide
Status:
COMPLETED
Status Verified Date:
2019-07
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:
PLATE NOX
Brief Summary:
Background
Acute coronary syndrome ACS is a term representing all diseases related to reduction in blood flow to the heart characterised by clot formation over a segment of blood vessel narrowing A major constituent of clot are blood cells called platelets and many of the medications used in ACS target platelet function Ticagrelor is known to reduce platelet activity in clot formation by blocking a specific step in the process P2Y12 receptors A recent study has found that the presence of ticagrelor may also reduce clot formation by significantly enhancing another process involving the molecule nitric oxide NO This is of particular interest if translates into clinical practice as many patients with heart disease have abnormal function of their blood vessel lining This is known to cause a reduction in available nitric oxide Does this therefore mean these patients will have a reduced response to ticagrelor therapy and subsequently be at increased risk of clot formation
Aims
1 Will ticagrelor increase the anti clot effect of vessel lining produced nitric oxide
2 Do patients with diabetes or smokers who have poor function of their vessel lining have a reduced response to ticagrelor
Methods
This is a pilot study in which we propose to look at 64 patients with known disease of their heart blood vessels with an equal mix of smokers diabetics smoking diabetics and non smoking non diabetics We will also recruit ten healthy normal subjects to ensure that our tests produce the same results as the basic science study mentioned above
To answer the questions posed we will perform blood tests primarily looking at platelet function and non-invasive blood vessel lining assessment This will be done before and after ticagrelor treatment on each participant enabling statistical comparison
Acute coronary syndrome ACS is a term representing all diseases related to reduction in blood flow to the heart characterised by clot formation over a segment of blood vessel narrowing A major constituent of clot are blood cells called platelets and many of the medications used in ACS target platelet function Ticagrelor is known to reduce platelet activity in clot formation by blocking a specific step in the process P2Y12 receptors A recent study has found that the presence of ticagrelor may also reduce clot formation by significantly enhancing another process involving the molecule nitric oxide NO This is of particular interest if translates into clinical practice as many patients with heart disease have abnormal function of their blood vessel lining This is known to cause a reduction in available nitric oxide Does this therefore mean these patients will have a reduced response to ticagrelor therapy and subsequently be at increased risk of clot formation
Aims
1 Will ticagrelor increase the anti clot effect of vessel lining produced nitric oxide
2 Do patients with diabetes or smokers who have poor function of their vessel lining have a reduced response to ticagrelor
Methods
This is a pilot study in which we propose to look at 64 patients with known disease of their heart blood vessels with an equal mix of smokers diabetics smoking diabetics and non smoking non diabetics We will also recruit ten healthy normal subjects to ensure that our tests produce the same results as the basic science study mentioned above
To answer the questions posed we will perform blood tests primarily looking at platelet function and non-invasive blood vessel lining assessment This will be done before and after ticagrelor treatment on each participant enabling statistical comparison
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 14YH0179 | OTHER | SouthYorks NRESCommitteeYorkandHumber- HEALTH RESEARCH AUTHORITY | None |