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| Name | Class |
|---|---|
| University of Hertfordshire | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel with Rivaroxaban | Experimental | Clopidogrel 75mg o.d. and Rivaroxaban 2.5mg b.i.d. |
|
| Clopidogrel | Active Comparator | Clopidogrel 75mg o.d. |
|
| Ticagrelor | Active Comparator | Ticagrelor 90mg b.i.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clopidogrel 75Mg Tablet | Drug | Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of further angioplasty | Clinical events including re-intervention | 6 months |
| Frequency of further heart attack, stroke or death | Incidence of further major adverse cardiac events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diana A Gorog, MD, PhD, FRCP | Contact | 01438 284 753 | d.gorog@nhs.net | |
| Ying X Gue, MBChB, MRCP | Contact | 01438 284 753 | y.gue@nhs.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East and North Hertfordshire NHS Trust | Recruiting | Stevenage | Hertfordshire | SG1 4AB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31872349 | Derived | Gue YX, Kanji R, Wellsted DM, Srinivasan M, Wyatt S, Gorog DA. Rationale and design of "Can Very Low Dose Rivaroxaban (VLDR) in addition to dual antiplatelet therapy improve thrombotic status in acute coronary syndrome (VaLiDate-R)" study : A randomised trial modulating endogenous fibrinolysis in patients with acute coronary syndrome. J Thromb Thrombolysis. 2020 Feb;49(2):192-198. doi: 10.1007/s11239-019-02014-5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 1, 2024 | |
| Reset | Oct 18, 2024 | |
| Release | Mar 31, 2025 |
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|
| Rivaroxaban 2.5Mg Tablet | Drug | Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel) |
|
|
| Ticagrelor 90Mg Tablet | Drug | Prevention of atherothrombotic events in patients with acute coronary syndrome [in combination with aspirin] |
|
|
| 6 months |
| Reset | Mar 31, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 1, 2024 | Oct 18, 2024 | |||
| Mar 31, 2025 | Mar 31, 2025 |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D000069552 | Rivaroxaban |
| D013607 | Tablets |
| D000077486 | Ticagrelor |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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