Acute Coronary SyndromePhase 4VaLiDate-RNCT03775746
Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS
A Phase 4 study testing Clopidogrel 75Mg Tablet, Rivaroxaban 2.5Mg Tablet and Ticagrelor 90Mg Tablet in people with Acute Coronary Syndrome, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Clopidogrel 75Mg Tablet, Rivaroxaban 2.5Mg Tablet and Ticagrelor 90Mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2019to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients aged 18 years or over
- Have a diagnosis of acute coronary syndrome requiring treatment with dual antiplatelet therapy
- Be willing and able to understand the Participant Information Sheet and provide informed consent
- Agree to comply with the drawing of blood samples for the assessments
- Not meet any of the exclusion criteria below
Who cannot join
- Male and female participants aged < 18 years of age.
- Patient unwilling or unable to give informed consent
- Patients who might be pregnant or are breast-feeding
- Active clinically significant bleeding
- Patient who, in the opinion of the investigator, has condition considered to be a significant risk for major bleeding (such as current or recent gastrointestinal ulceration, presence of malignant neoplasm at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities)
- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk including cirrhotic patients with Child Pugh B and C
Show all 13Show fewer
- Patient with any contraindications to use of antiplatelet agents or anticoagulants
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of Summary of Product Characteristics (SmPC) of Rivaroxaban
- Concomitant treatment with any other anticoagulants e.g. unfractionated heparin (UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, dabigatran etexilate, apixaban etc.) except under specific circumstances of switching anticoagulant therapy or when UFH is given at doses necessary to maintain an open central venous or arterial catheter
- Concomitant treatment of ACS with antiplatelet therapy in patients with a prior stroke or a transient ischaemic attack (TIA)
- Patient with ongoing active alcohol or substance abuse or demonstrates signs or clinical features of active substance abuse.
- Patient with any major bleeding diathesis or blood dyscrasia at baseline (platelets<70 x 109/l, Hb<80 g/l, INR>1.4, APTT> x 2UNL, leucocyte count< 3.5x 109/l, neutrophil count<1x 109/l)
- Patient currently enrolled in an investigational drug trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
East and North Hertfordshire NHS Trust
Stevenage, Hertfordshire, SG1 4AB
Diana A Gorog, +44(0)1707 247512, d.gorog@nhs.net
Ying Gue, +44(0)1438 284753, y.gue@nhs.net
About this study
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.
Read the detailed description
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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Clopidogrel 75Mg Tablet, Rivaroxaban 2.5Mg Tablet, Ticagrelor 90Mg Tablet
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel 75Mg TabletDrug
Also called EU/1/08/465/001
Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel
Rivaroxaban 2.5Mg TabletDrug
Also called EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047
Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel)
Ticagrelor 90Mg TabletDrug
Also called EU/1/10/655/007-011
Prevention of atherothrombotic events in patients with acute coronary syndrome [in combination with aspirin]
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel with Rivaroxaban | Experimental | Clopidogrel 75mg o.d. and Rivaroxaban 2.5mg b.i.d. Receives: Drug: Clopidogrel 75Mg Tablet; Drug: Rivaroxaban 2.5Mg Tablet |
| Clopidogrel | Active comparator | Clopidogrel 75mg o.d. Receives: Drug: Clopidogrel 75Mg Tablet |
| Ticagrelor | Active comparator | Ticagrelor 90mg b.i.d. Receives: Drug: Ticagrelor 90Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
Frequency of further angioplasty
Clinical events including re-intervention
Measured: 6 months
Frequency of further heart attack, stroke or death
Incidence of further major adverse cardiac events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study start8 Jan 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hertfordshire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03775746
- Sponsor's protocol ID
- RD2018-41
- Acronym
- VaLiDate-R
- Status last verified
- Feb 2020
- First submitted
- 12 Dec 2018
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31872349
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Very Low Dose Rivaroxaban in Addition to Dual Antiplatelet Therapy (DAPT) Improve Thrombotic Status in Acute Coronray Syndrome (ACS) ACS
- ClinicalTrials.gov ID
- NCT03775746
- Acronym / sponsor ID
- VaLiDate-R / RD2018-41
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Collaborators
- University of Hertfordshire
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel with Rivaroxaban | Experimental | Drug: Clopidogrel 75Mg Tablet, Drug: Rivaroxaban 2.5Mg TabletClopidogrel 75mg o.d. and Rivaroxaban 2.5mg b.i.d. |
| Clopidogrel | Active comparator | Drug: Clopidogrel 75Mg TabletClopidogrel 75mg o.d. |
| Ticagrelor | Active comparator | Drug: Ticagrelor 90Mg TabletTicagrelor 90mg b.i.d. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients aged 18 years or over
- Have a diagnosis of acute coronary syndrome requiring treatment with dual antiplatelet therapy
- Be willing and able to understand the Participant Information Sheet and provide informed consent
- Agree to comply with the drawing of blood samples for the assessments
- Not meet any of the exclusion criteria below
Key exclusion criteria (13 listed)
- Male and female participants aged < 18 years of age.
- Patient unwilling or unable to give informed consent
- Patients who might be pregnant or are breast-feeding
- Active clinically significant bleeding
- Patient who, in the opinion of the investigator, has condition considered to be a significant risk for major bleeding (such as current or recent gastrointestinal ulceration, presence of malignant neoplasm at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clopidogrel 75Mg TabletAlso: EU/1/08/465/001Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel | Drug | Clopidogrel, Clopidogrel with Rivaroxaban |
| Rivaroxaban 2.5Mg TabletAlso: EU/1/08/472/025-035, EU/1/08/472/041, EU/1/08/472/046-047Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel) | Drug | Clopidogrel with Rivaroxaban |
| Ticagrelor 90Mg TabletAlso: EU/1/10/655/007-011Prevention of atherothrombotic events in patients with acute coronary syndrome [in combination with aspirin] | Drug | Ticagrelor |
Primary outcome
The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 30 days
Time frame: 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
2 secondary outcomes
Frequency of further angioplasty
Time frame: 6 months
Frequency of further heart attack, stroke or death
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Derived from this study: PubMed 31872349Gue 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Clopidogrel 75Mg Tablet, Rivaroxaban 2.5Mg Tablet and Ticagrelor 90Mg Tablet in people with Acute Coronary Syndrome, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diana A Gorog, MD, PhD, FRCP (01438 284 753, d.gorog@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03775746, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.