Can additional treatment with a third blood thinning medication reduce the risk of further clots in heart arteries, in patients with a recent heart attack who are already taking two blood thinning medications.

Can Very Low Dose Rivaroxaban (VLDR) in addition to dual antiplatelet therapy (DAPT) improve thrombotic status in acute coronary syndrome (ACS) - VaLiDate-R

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-003299-11-GB

Enrollment

150

Registered

2018-08-30

Start date

2018-10-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Rivaroxaban Product Name: Rivaroxaban Pharmaceutical Form: Tablet INN or Proposed INN: Rivaroxaban CAS Number: 366789-02-8

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged 18 years or over 2. Have a diagnosis of acute coronary syndrome requiring treatment with dual antiplatelet therapy 3. Be willing and able to understand the Participant Information Sheet and provide informed consent 4. Agree to comply with the drawing of blood samples for the assessments 5. Not meet any of the exclusion criteria below Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 120 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: 1. Male and female participants aged 1.4, APTT> x 2UNL, leucocyte count< 3.5x 109/l, neutrophil count<1x 109/l) 13. Patient currently enrolled in an investigational drug trial

Design outcomes

Primary

Measure	Time frame
Secondary Objective: None;Primary end point(s): The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 4 weeks.;Timepoint(s) of evaluation of this end point: Repeated measures ANOVA will be undertaken to evaluate LT across the 3 groups and across the 3 time points (2 weeks, 4 weeks and 8 weeks). Paired comparisons focussing on low dose rivaroxaban (Group 2) will also be performed.;Main Objective: The aim of this study is to identify patients with a recent heart attack (acute coronary syndrome), who despite standard treatment with dual antiplatelet therapy, demonstrate on a research blood test, that they have a propensity to form lasting clots (impaired endogenous fibrinolysis). We then aim to assess whether low dose rivaroxaban (in addition to dual antiplatelet therapy) can reduce the chance of clot formation (as shown on a research blood test). This would mean we can target this additional treatment to all patients who are shown to be more at risk of further clots, to reduce their future chance of a heart attack.	—

Measure

Time frame

Secondary Objective: None;Primary end point(s): The change in Lysis Time (LT) in the three treatment groups assessed using the GTT from admission to follow-up at 4 weeks.;Timepoint(s) of evaluation of this end point: Repeated measures ANOVA will be undertaken to evaluate LT across the 3 groups and across the 3 time points (2 weeks, 4 weeks and 8 weeks). Paired comparisons focussing on low dose rivaroxaban (Group 2) will also be performed.;Main Objective: The aim of this study is to identify patients with a recent heart attack (acute coronary syndrome), who despite standard treatment with dual antiplatelet therapy, demonstrate on a research blood test, that they have a propensity to form lasting clots (impaired endogenous fibrinolysis). We then aim to assess whether low dose rivaroxaban (in addition to dual antiplatelet therapy) can reduce the chance of clot formation (as shown on a research blood test). This would mean we can target this additional treatment to all patients who are shown to be more at risk of further clots, to reduce their future chance of a heart attack.

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Secondary

Measure	Time frame
Secondary end point(s): Clinical events including re-intervention (further angioplasty), major adverse cardiac events (composite of heart attack, stroke or death) and bleeding events.;Timepoint(s) of evaluation of this end point: Clinical events will be evaluated at all follow up visits (2, 4, 8 weeks and 6 months post randomisation)	—

Countries

United Kingdom

Contacts

Public ContactMs Rishma Bhatti

East and North Hertfordshire NHS Trust

researchanddevelopment.enh-tr@nhs.net02038262075

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 28, 2026