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P2Y12 receptor inhibitor

Ticagrelor for Heart Attacks and Stable Angina

Phase 4

Waitlist Available

Led By Paul Gurbel, MD

Research Sponsored by LifeBridge Health

Eligibility Criteria Checklist

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

Must have

a positive test of a biomarker (troponin I) in accordance with the universal definitions indicating myocardial necrosis

STEMI

Must not have

Severely impaired renal function (glomerular filtration rate < 30 mL/minute) or on dialysis

Concomitant oral or intravenous therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-ld dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study md dose (14 +/- 3 days).

Awards & highlights

Drug Has Already Been Approved

All Individual Drugs Already Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial finds that ticagrelor is associated with less cardiovascular events and all-cause mortality than clopidogrel in patients with acute coronary syndromes.

Who is the study for?

This trial is for patients with stable angina or those who have had a recent heart attack (STEMI, NSTEMI) and are undergoing PCI. They must show signs of ischemia or myocardial necrosis. Excluded are those on certain blood thinners, with severe liver/heart issues, uncontrolled hypertension, recent stroke/TIA, or severe renal impairment.

What is being tested?

The study tests ticagrelor's effectiveness in platelet inhibition during PCI across different heart conditions: stable angina and acute coronary syndromes like STEMI and NSTEMI. It aims to confirm if ticagrelor works equally well irrespective of the patient's specific condition.

What are the potential side effects?

Ticagrelor can cause bleeding problems, shortness of breath, irregular heartbeat risks, increased bruising risk due to reduced blood clotting ability; it may also interact with other medications affecting its function.

Eligibility Criteria

Inclusion Criteria

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

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My heart test shows damage to the heart muscle.

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I have had a severe heart attack.

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I have stable heart disease and am scheduled for a procedure to open my heart's arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely impaired or I am on dialysis.

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I am not taking strong medication that affects liver enzymes and can't stop them for the study.

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I do not have drug/alcohol abuse issues and my blood and kidney tests are within normal ranges.

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I cannot take ticagrelor due to health reasons.

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I have received or will receive clot-dissolving drugs around my heart procedure.

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My liver enzyme ALT levels are more than 2.5 times the upper limit.

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I have a history of severe irregular heartbeats or am at high risk for slow heart rates.

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I am currently taking medication for blood clots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-ld dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study md dose (14 +/- 3 days).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-ld dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study md dose (14 +/- 3 days).

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-ld dose, 0.5, 1, 2, 3, 4-6, the next day just before and 1, 2 and 4 hours after morning maintenance dose and pre-dose and 1, 2 and 4 hours after the last study md dose (14 +/- 3 days). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inhibition of platelet aggregation

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TicagrelorExperimental Treatment1 Intervention

As per ACC/AHA and ESC guidelines 180 mg is the recommended LD. The ticagrelor 90 mg BID dose, following the loading dose, has been selected for the clopidogrel naïve patients with stable angina, NSTEMI and STEMI patients undergoing PCI as the maintenance dose for this study since it is the FDA recommended dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ticagrelor

FDA approved

0 / 11Eligibility criteria met