NCT05764356

Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II (IMPACT 2)

Not yet recruiting Last updated 1 March 2023

What this trial tests

trial testing Detection of genotype and RNA profile in platelet and white blood cell in Novel Oral Anticoagulants in 2,000 participants. Not yet recruiting.

Timeline

1 March 2023

Primary endpoint
1 December 2026

1 December 2027

Quick facts

Lead sponsor	Peking University First Hospital
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	2,000
Start date	1 March 2023
Primary completion	1 December 2026
Estimated completion	1 December 2027
Sites	6 locations across China

Drugs / interventions tested

• Detection of genotype and RNA profile in platelet and white blood cell
• Indicators test related to coagulation function
• Indicators test related to platelet function

Conditions studied

• Novel Oral Anticoagulants — all drugs for Novel Oral Anticoagulants →
• NOACs — all drugs for NOACs →
• Rivaroxaban — all drugs for Rivaroxaban →
• Apixaban — all drugs for Apixaban →

Sponsor

Peking University First Hospital

Who can join

18 and older, any sex, with Novel Oral Anticoagulants or NOACs. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of new bleeding events
  Time frame: Within 1 month after enrollment
  During the observation time, record the incidence of new bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.
• Incidence of new bleeding events
  Time frame: From 1 month to 6 months after enrollment
  During the observation time, record the incidence of new 'bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.
• Incidence of new bleeding events
  Time frame: From 6 months to 1 year after enrollment
  During the observation time, record the incidence of new bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.
• Incidence of new bleeding events
  Time frame: From 1 year to 2 years after enrollment
  During the observation time, record the incidence of new bleeding events after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.
• Incidence of new major cardiovascular events and all-cause death
  Time frame: Within 1 month after enrollment
  During the observation time, record the new incidence of major cardiovascular events (MACEs) and all-cause death after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic. MACEs including cardiac death, myocardial infarction (MI), stroke or transient cerebral thrombus (TIA), ischemic-driven coronary revascularization(PCI, CABG, thromb
• Incidence of new major cardiovascular events and all-cause death
  Time frame: From 1 month to 6 months after enrollment
  During the observation time, record the new incidence of major cardiovascular events (MACEs) and all-cause death after NOACs(rivaroxaban, apixaban, edoxaban, dabigatran) or ticagrelor administration by telephone and out-patient clinic. MACEs including cardiac death, myocardial infarction (MI), stroke or transient cerebral thrombus (TIA), ischemic-driven coronary revascularization(PCI, CABG, thromb

Sponsor's own description

Individual differences in drug efficacy and adverse reactions are common in the clinical application of drugs. Individual differences are caused by many factors, among which genetic factors account for more than 20%. Novel oral anticoagulant drugs (NOACs, including rivaroxaban, apixaban, edoxaban, dabigatran, etc.) and novel antiplatelet drug ticagrelor have the advantages of convenient use and no need for monitoring. But novel oral antithrombotic drugs also increase the risk of bleeding, and there is currently a lack of effective antagonists when antithrombosis is excessive or emergency surgery is required. At present, there are few studies on the causes of individual differences in novel antithrombotic drugs, and there is a lack of predictable biomarkers or drug genotypes, especially in China. Therefore, on the basis of previous studies on NOACs and ticagrelor individualized medication cohorts, this study plans to establish a validation cohort for novel antithrombotic drugs bleeding related biomarkers, conduct multi-omics testing and long-term follow-up, and explore markers related to pharmacodynamics of antithrombotic drugs, adverse bleeding reactions and clinical outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.