Acute Coronary SyndromePhase 4NCT01603082

Ad Hoc Percutaneous Coronary Intervention Study in Acute Coronary Syndrome Patients

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome, run by AstraZeneca at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI Read more about this study

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Ticagrelor and Clopidogrel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 343 participants
Where: 16 sitesUnited States
Study dates: Jul 2012to Jun 2014
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of signed and dated informed consent before initiation of any study-related procedures
Male or female patients aged 18 years or older
Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI)
Females must be post menopausal or surgically sterile
Taking aspirin as an anti-platelet medication

Who cannot join

Use of any thienopyridine or ticagrelor within 7 days prior to randomization
Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve)
Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis
History of intolerance or allergy to aspirin

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Research Site
Belleville, New Jersey
Research Site
Birmingham, Alabama
Research Site
Cincinnati, Ohio
Research Site
Greensboro, North Carolina
Research Site
Jacksonville, Florida
Research Site
Minneapolis, Minnesota
Research Site
New York, New York
Research Site
North Kansas City, Missouri
Research Site
Oklahoma City, Oklahoma
Research Site
Richmond, Virginia
Research Site
San Francisco, California
Research Site
The Bronx, New York
Research Site
Tupelo, Mississippi
Research Site
Tyler, Texas
Research Site
Washington D.C., District of Columbia
Research Site
Ypsilanti, Michigan

Other trials in United States

About this study

Official title: A Randomized, Open-label Study to Compare the Platelet Inhibition With VerifyNow Assay of Ticagrelor Versus Clopidogrel in Troponin Negative Acute Coronary Syndrome Subjects Undergoing Ad Hoc Percutaneous Coronary Intervention

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

Read the detailed description

A randomized, open-label, multiple-center, parallel group study to compare the platelet inhibition with VerifyNow assay of ticagrelor versus clopidogrel in troponin negative Acute Coronary Syndrome (ACS) subjects undergoing Ad Hoc percutaneous coronary intervention (PCI)

Conditions: Acute Coronary Syndrome
Being tested: Ticagrelor, Clopidogrel
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TicagrelorDrug
180 mg loading dose
ClopidogrelDrug
600 mg loading dose

Study groups in NCT01603082
Study group	Role	What they receive
Ticagrelor	Experimental	Ticagrelor - 180 mg loading dose Receives: Drug: Ticagrelor
Clopidogrel	Active comparator	Clopidogrel - 600 mg loading dose Receives: Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™
Participants with low (<150) baseline PRU values were excluded.
Measured: 2 hours after the loading dose

Secondary outcomes (1)

Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™
Participants with low (<150) baseline PRU values were excluded.
Measured: 0.5 hours, end of PCI, and 8 hours after the loading dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2012Jun 2014

First posted22 May 2012 (estimated)
Study startJul 2012
Primary completionJun 2014
Study completionJun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 343 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01603082
Sponsor's protocol ID: D5130L00014
Status last verified: Nov 2015
First submitted: 18 May 2012
Last updated: 11 Dec 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sweeny JM, Angiolillo DJ, Franchi F, Rollini F, Waksman R, Raveendran G, Dangas G, Khan ND, Carlson GF, Zhao Y, Teng R, Mehran R. Impact of Diabetes Mellitus on the Pharmacodynamic Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Ad Hoc Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Mar 29;6(4):e005650. doi: 10.1161/JAHA.117.005650.
PubMed 28356282
Angiolillo DJ, Franchi F, Waksman R, Sweeny JM, Raveendran G, Teng R, Zhao Y, Carlson G, Khan N, Mehran R. Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Patients With Low-Risk ACS Undergoing Ad Hoc PCI. J Am Coll Cardiol. 2016 Feb 16;67(6):603-613. doi: 10.1016/j.jacc.2015.11.044.
PubMed 26868683

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study to Compare the Platelet Inhibition With VerifyNow Assay of Ticagrelor Versus Clopidogrel in Troponin Negative Acute Coronary Syndrome Subjects Undergoing Ad Hoc Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT01603082
Acronym / sponsor ID: D5130L00014
Conditions: Acute Coronary Syndrome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 343 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Jun 2014 (actual)
Study completion: Jun 2014 (actual)
First posted: 22 May 2012 (estimated)
Results: Posted 11 Dec 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in ACS patients undergoing an Ad Hoc PCI

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Ticagrelor	Experimental	Drug: TicagrelorTicagrelor - 180 mg loading dose
Clopidogrel	Active comparator	Drug: ClopidogrelClopidogrel - 600 mg loading dose

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of signed and dated informed consent before initiation of any study-related procedures
Male or female patients aged 18 years or older
Documented acute coronary syndrome and troponin negative and undergoing Ad Hoc percutaneous coronary intervention (PCI)
Females must be post menopausal or surgically sterile
Taking aspirin as an anti-platelet medication

Key exclusion criteria (4 listed)

Use of any thienopyridine or ticagrelor within 7 days prior to randomization
Any indication for oral anticoagulant (e.g., atrial fibrillation, mitral stenosis or prosthetic heart valve)
Contraindication that ticagrelor or clopidogrel should not be administered Patient requires dialysis
History of intolerance or allergy to aspirin

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ticagrelor180 mg loading dose	Drug	Ticagrelor
Clopidogrel600 mg loading dose	Drug	Clopidogrel

Primary outcome

Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™
Time frame: 2 hours after the loading dose
Participants with low (<150) baseline PRU values were excluded.

1 secondary outcome

Inhibition of the P2Y12 Receptor at 0.5 Hours, End of PCI, and 8 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by PRU From VerifyNow™
Time frame: 0.5 hours, end of PCI, and 8 hours after the loading dose

Results and safety

Results posted to the registry on 11 Dec 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ticagrelor	51	49
Clopidogrel	49	48

Primary outcome: Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™

Time frame: 2 hours after the loading dose. Mean (Standard Deviation). Unit: PRU

Measure	Ticagrelor n = 45	Clopidogrel n = 46
Value	98.4 (95.4)	257.5 (74.5)

Ticagrelor vs Clopidogrel: Mean Difference (Final Values): -159.1 (95% CI -194.7 to -123.5), p <0.001, t-test, 2 sided

Population analysed: Pharmacodynamic (PD) Analysis Set (N=93; 46 on ticagrelor, 47 on clopidogrel) - included all participants with PD data and without a major protocol deviation thought to significantly affect the PD of ticagrelor or clopidogrel. Participants in the PD Analysis Set with low (\<150) baseline PRU values were excluded from the analyses.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All adverse events (AEs), including serious AEs were monitored from the point of informed consent through the 14 day follow up period. All vascular events were assessed at each visit and could be reported by participants at any time during the study.. Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ticagrelor	9 of 51 (17.6%)	5 of 51 (9.8%)	Not reported
Clopidogrel	5 of 49 (10.2%)	1 of 49 (2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28356282Sweeny JM, Angiolillo DJ, Franchi F, Rollini F, Waksman R, Raveendran G, Dangas G, Khan ND, Carlson GF, Zhao Y, Teng R, Mehran R. Impact of Diabetes Mellitus on the Pharmacodynamic Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Acute Coronary Syndrome Patients Undergoing Ad Hoc Percutaneous Coronary Intervention. J Am Heart Assoc. 2017 Mar 29;6(4):e005650. doi: 10.1161/JAHA.117.005650.
Derived from this study: PubMed 26868683Angiolillo DJ, Franchi F, Waksman R, Sweeny JM, Raveendran G, Teng R, Zhao Y, Carlson G, Khan N, Mehran R. Effects of Ticagrelor Versus Clopidogrel in Troponin-Negative Patients With Low-Risk ACS Undergoing Ad Hoc PCI. J Am Coll Cardiol. 2016 Feb 16;67(6):603-613. doi: 10.1016/j.jacc.2015.11.044.

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Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Glenn F. Carlson, MD study director

AstraZeneca Pharmaceuticals, Wilmington, DE 19850-5437 USA

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome, run by AstraZeneca at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inhibition of the P2Y12 Receptor at 2 Hours After Loading Doses of Ticagrelor and Clopidogrel as Measured by P2Y12 Reaction Units (PRU) From VerifyNow™ (time frame: 2 hours after the loading dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01603082, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.