- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02219412
Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable CAD Treated With Ticagrelor Monotherapy
An Open Label, Two Arms, Randomized Controlled Pilot Study Comparing the Arachidonic Acid-induced Platelet Aggregation Rate in Patients With Stable Coronary Artery Disease Treated With Ticagrelor Monotherapy or Ticagrelor and Asprin
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This is a randomized, open labeled, active-controlled pilot study to estimate the difference of arachidonic acid induced platelet aggregation rate between ticagrelor monotherapy and aspirin/ticagrelor dual-therapy in patients with stable coronary heart disease. The anticipated duration of the study is approximately 9 months, including an anticipated enrolment period of 8 months and follow-up period of 4weeks.
Patients with documented coronary heart disease and currently receiving dual-antiplatelet therapy with standard dose aspirin and clopidogrel will be enrolled from the study site. For patients post acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI), they must be on dual-antiplatelet therapy for at least 12 months to be eligible for the study.
The study plan, including enrolment/randomization and follow-up visits, is outlined in Table 1. Eligible patients will enter a washout phase with ticagrelor for 2 weeks. Then they will be randomized to take either ticagrelor alone or aspirin/ticagrelor for 14 days. The efficacy evaluation will be done at 7 and 14days after randomization. The primary efficacy parameter is the rate of arachidonic acid induced platelet aggregation after 14 days of treatment. All patients will be treated to standards of care for coronary heart disease secondary prevention.
Visit 0 (Screening and Enrollment, 0 day) All potentially eligible patients will undergo a screening visit following their signed informed consent.
Following an 8-hour fast, the patients will have screening evaluations performed. Demography, medical history, and concomitant medication will be recorded. A physical examination and vital signs(pulse and BP), height and weight, as well as blood sampling for laboratory assessments of complete blood count (CBC) with differential, serum creatinine, alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and AA, adenosine diphosphate (ADP) and collagen induced platelet aggregation rate will be done. Standard 12-lead electrocardiogram (ECG) readings will be recorded.
Patients meeting all inclusion criteria and with no exclusion criteria will be enrolled. Patients will receive ticagrelor mono-therapy from the evening for 14 days. IP will be dispensed.
Visit 1 (Randomization, 14 days) Suspected adverse events (AEs) will be recorded. A physical examination and vital signs (pulse and BP), as well as blood sampling for laboratory assessments of AA, ADP and collagen induced platelet aggregation rate and serum thromboxane B2 concentration will be done.
Patients should be told to take ticagrelor in the morning of Visit 1. Patients will be randomized in a 1:1 ratio to receive either ticagrelor mono-therapy or aspirin/ticagrelor dual-therapy. Investigational product (IP) will be returned and compliance assessed and new bottles of IP will be dispensed according to randomized groups.
Visit 2 (21 days) Suspected AEs will be recorded. Vital signs (pulse and BP) as well as blood sampling for laboratory assessments of AA, ADP and collagen induced platelet aggregation rate will be done.
Visit 3 (End of treatment, 28 days) Suspected AEs will be recorded. Vital signs (pulse and BP) as well as blood sampling for laboratory assessments of CBC with differential, Scr, ALT and AST, AA, ADP and collagen induced platelet aggregation rate will be done. IP will be returned and compliance assessed. Instructions for medication after study will be given to patients at this time.
For patients who prematurely discontinued the randomized treatment, a complete end of treatment visit will be preferred.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
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Beijing, Cina, 100034
- Peking University First Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures.
- Aged >18 years.
- Documented stable coronary artery disease.
- Currently receiving dual-antiplatelet therapy with aspirin 100mg/d and clopidogrel 75mg/d.
Exclusion Criteria:
- History of acute coronary syndrome within 12 months of screening.
- History of percutaneous coronary intervention within 12 months of screening.
- Any indication (eg, atrial fibrillation,prosthetic heart valve, or coronary stent) for antithrombotic therapy(eg, warfarin, clopidogrel, or aspirin dose other than 75 to 100 mg/during the study period).
- AA induced platelet aggregation rate >20% on aspirin+clopidogrel measured by light transmission platelet aggregation test with the past 3 months.
- Congestive heart failure or left ventricular ejection fraction <35%.
- Forced expiratory volume in the first second forced vital capacity below the lower limits of normal.
- Bleeding diathesis or severe pulmonary disease.
- Active pathological bleeding.
- History of intracranial hemorrhage.
- Hypersensitivity to ticagrelor or any of the excipients.
- Severe hepatic impairment.
- Pregnancy.
- Current smoking.
- Platelet count <100 000/mm3 or hemoglobin <10 g/dL.
- HemoglobinA1c >10%.
- History of drug addiction or alcohol abuse in the past 2 years.
- Need for nonsteroidal anti-inflammatory drug.
- Creatinine clearance<30 mL/min.
- Concomitant therapy with moderate or strong cytochrome P450 3A inhibitors, substrates, or strong cytochrome P450 3A inducers.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: ticagrelor mono-therapy
Take ticagrelor 90 mg Bid for 2 weeks.
|
90 mg bid for 2 weeks
Altri nomi:
|
Comparatore attivo: aspirin/ticagrelor dual-therapy
Take ticagrelor 90mg Bid plus Aspirin 100mg Qd and treated for 2 weeks.
|
90 mg bid for 2 weeks
Altri nomi:
100mg Qd for 2 weeks.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The rate of AA induced platelet aggregation
Lasso di tempo: Day 14 after randomization
|
The rate of AA induced platelet aggregation will be measured at day 14 after randomization.
|
Day 14 after randomization
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
The rate of ADP induced platelet aggregation
Lasso di tempo: Day 7 and day 14 after randomization
|
The rate of ADP induced platelet aggregation will be measured at day 7 and day 14 after randomization.
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Day 7 and day 14 after randomization
|
The rate of collagen induced platelet aggregation
Lasso di tempo: Day 7 and day 14 after randomization
|
The rate of d collagen induced platelet aggregation will be measured at day 7 and day 14 after randomization.
|
Day 7 and day 14 after randomization
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The serum concentration of Thromboxane B2
Lasso di tempo: Day 7 and day 14 after randomization
|
The serum concentration of Thromboxane B2 will be measured at day7 and day 14 after randomization
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Day 7 and day 14 after randomization
|
The rate of AA induced platelet aggregation
Lasso di tempo: Day 7 after randomization
|
The rate of collagen induced platelet aggregation will be measured on Day 7 after randomization
|
Day 7 after randomization
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Huo Yong, MD, Peking University First Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattia cardiovascolare
- Malattie vascolari
- Arteriosclerosi
- Malattie arteriose occlusive
- Malattie cardiache
- Disfunsione dell'arteria coronaria
- Ischemia miocardica
- Malattia coronarica
- Effetti fisiologici delle droghe
- Agenti neurotrasmettitori
- Meccanismi molecolari dell'azione farmacologica
- Agenti del sistema nervoso periferico
- Inibitori enzimatici
- Analgesici
- Agenti del sistema sensoriale
- Agenti antinfiammatori, non steroidei
- Analgesici, non narcotici
- Agenti antinfiammatori
- Agenti antireumatici
- Agenti fibrinolitici
- Agenti modulanti la fibrina
- Inibitori dell'aggregazione piastrinica
- Inibitori della ciclossigenasi
- Antipiretici
- Antagonisti del recettore purinergico P2Y
- Antagonisti del recettore purinergico P2
- Antagonisti purinergici
- Agenti purinergici
- Aspirina
- Ticagrelor
Altri numeri di identificazione dello studio
- ISSBRIL0235
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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