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P2Y12 receptor antagonist

Low-Dose Ticagrelor for Acute Coronary Syndrome

Phase 3

Waitlist Available

Research Sponsored by First Affiliated Hospital of Harbin Medical University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalized for NSTE-ACS within the preceding 48 h

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study (from baseline to 12 hours after the last dose)

Awards & highlights

Study Summary

This trial looks at whether a lower dose of the drug ticagrelor is just as effective as the conventional dose in preventing atherothrombotic events (heart attacks and strokes) in patients with acute coronary syndromes, with a particular focus on East Asian patients.

Who is the study for?

This trial is for Chinese patients with non-ST-elevation acute coronary syndromes (NSTE-ACS) who have had symptoms like chest pain at rest, certain ECG changes, or elevated heart markers. They must have been hospitalized within the last 48 hours and could have had a previous heart attack or procedure to open their arteries. People can't join if they've had a stroke, severe bleeding issues, very low platelet counts or kidney function, planned use of other specific heart drugs during the study, or allergies to aspirin and related medications.Check my eligibility

What is being tested?

The trial tests three different blood-thinning treatments in patients with NSTE-ACS: conventional-dose ticagrelor (90 mg twice daily), low-dose ticagrelor (45 mg twice daily), and clopidogrel (75mg once daily). It aims to find out which dose of ticagrelor works best for Chinese patients by comparing their effects on platelet activity without causing too much bleeding.See study design

What are the potential side effects?

Possible side effects include increased risk of bleeding due to the blood-thinning nature of these medications. Patients may also experience shortness of breath or allergic reactions. The severity and type of side effects can vary based on the dosage and individual patient characteristics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I was hospitalized for a heart condition within the last 2 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before dosing (baseline) and up to 12 hours after the last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before dosing (baseline) and up to 12 hours after the last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and before dosing (baseline) and up to 12 hours after the last dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

the differences in mean inhibition of platelet aggregation or inhibition ratio (%)

Secondary outcome measures

Number of bleeding events

Number of difficulty breathing events

number of death events

+4 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: low-dose ticagrelorExperimental Treatment1 Intervention

To observe the safety and efficacy of low-dose ticagrelor in Chinese patients with non-ST-elevation acute coronary syndrome

Group II: clopidogrelActive Control1 Intervention

To observe the different safety and efficacy between low-dose ticagrelor and conventional-dose clopidogrel.

Group III: conventional-dose ticagrelorActive Control1 Intervention

To observe the different safety and efficacy between low-dose ticagrelor and conventional-dose ticagrelor.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ticagrelor

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

First Affiliated Hospital of Harbin Medical UniversityLead Sponsor

136 Previous Clinical Trials

1,370,312 Total Patients Enrolled

Media Library

Clopidogrel (P2Y12 receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT02415803 — Phase 3

Myocardial Infarction Research Study Groups: low-dose ticagrelor, clopidogrel, conventional-dose ticagrelor

Myocardial Infarction Clinical Trial 2023: Clopidogrel Highlights & Side Effects. Trial Name: NCT02415803 — Phase 3

Clopidogrel (P2Y12 receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02415803 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to sign up for this clinical trial at the present moment?

"No, this study is not looking for new participants. However, there are other trials with similar eligibility requirements that have open recruitment policies."

Answered by AI

What are the risks associated with ticagrelor use at lower doses?

"Low-dose ticagrelor is considered safe, with a score of 3 on our team's power scale. This is because there is some data indicating its efficacy and multiple rounds of safety data supporting it."

Answered by AI

How is ticagrelor most commonly used by doctors?

"Ticagrelor can be used at low doses to treat myocardial infarction, stent placement, cerebrovascular accident, and coronary artery disease."

Answered by AI

Does this research project welcome seniors as participants?

"The age limit for this trial is between 18-75. If a patient falls outside of that bracket, there are still options; 389 trials exist for people under 18 and 1163 for those over 65."

Answered by AI

Do we have any other precedents for using ticagrelor in small dosages?

"As of now, there are 82 ongoing studies related to low-dose ticagrelor. Of these, 21 are Phase 3 trials. The majority of research facilities for this treatment are based in Beijing; however, there are 873 total locations running trials worldwide."

Answered by AI

Are there specific prerequisites for subjects in this experiment?

"Acute coronary syndrome sufferers between the ages of 18 and 75 are encouraged to apply for this trial. The most important requirements for participants are as follows: horizontal or down-sloping ST segment depression ≥0.1 mV;, ischemic symptoms at rest, lasting ≥10 minutes;."

Answered by AI

How many people are involved in this clinical trial at the largest possible scale?

"Unfortunately, this particular trial is not admitting patients at the current moment. However, if you explore other options there are 1503 trials for acute coronary syndrome and 82 studies involving low-dose ticagrelor that are still enrolling individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Efficacy of Low-Dose Ticagrelor in Chinese Patients With NSTE-ACS

2014. "Safety and Efficacy of Low-Dose Ticagrelor in Chinese Patients With NSTE-ACS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02415803.

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