Coronary Artery DiseasePhase 4OPTIMA-2NCT01955200

OPTImal Management of Antithrombotic Agents: OPTIMA-2 Trial

A Phase 4 study testing Clopidogrel, Cilostazol and Ticagrelor in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Completed

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

Official record

Search all trials

Trial summary

High on-treatment platelet reactivity (HOPR) is associated with increased risk of cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). We sought to investigate the efficacy and safety of 1-month intensified antiplatelet therapies in post-PCI patients with HOPR. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease
What is being tested?: Clopidogrel, Cilostazol and Ticagrelor
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,724 participants
Where: 1 siteChina
Study dates: 5 Oct 2013to 28 Nov 2017
Phase: Phase 4
Are there results?: None posted in the registry

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Successively recruit all patients who receive stent implantation;
Intended use of standard DAPT with the combination of aspirin 100mg once daily and clopidogrel 75mg once daily for at least 12 months;
Patient aged >18 years and ≦80 years old;
Signed inform consent.

Who cannot join

Allergy or intolerance to study drugs;
History of gastrointestinal or intracranial bleeding;
Need for anticoagulant therapy;
High risk of bleeding (e.g., myelodysplasia, baseline platelet count < 80 × 109/L);
Hemoglobin < 90g/L;
Active malignancy or life expectancy < 1 year;
Patients with other conditions made them unsuitable to be recruited at the discretion of the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029

Other trials in China

About this study

Official title: Intensified Antiplatelet Therapy in Post-PCI Patients With High On-treatment Platelet Reactivity: the OPTIMA-2 Trial

Read the detailed description

OPTImal Management of Antithrombotic agents: OPTIMA-2 trial

Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 receptor inhibitor is the foundation antiplatelet therapy in patients undergoing percutaneous coronary intervention (PCI). Clopidogrel is the most commonly used P2Y12 receptor inhibitor worldwide because it is effective and inexpensive1. High on-treatment platelet reactivity (HOPR) occurs in as many as one-third of patients treated with standard dose clopidogrel (75mg once daily), and is associated with an increased risk of major adverse cardiovascular events (MACE).

Various approaches have been tested to overcome HOPR in patients treated with aspirin and clopidogrel, including higher doses of clopidogrel; the addition of cilostazol; and replacement of clopidogrel with prasugrel; however, the results of these intensified treatments were controversial, and a more potent P2Y12 receptor inhibitor, ticagrelor has never been studied in this scenario.

TOPIC study showed that short-term (i.e. 1-month) intensification of antiplatelet treatment might be sufficient to achieve optimal outcomes. Similarly, TROPICAL ACS showed that guided de-escalation of antiplatelet treatment with clopidogrel was non-inferior to the treatment with prasugrel at 1 year after PCI in terms of net clinical benefit, which suggests that routinely long-term intensification of antiplatelet treatment is not required for all PCI patients.

Accordingly we performed a randomized trial to test the hypothesis that in patients with HOPR intensification of antiplatelet therapy with double dose clopidogrel, the addition of cilostazol, or replacement of clopidogrel with ticagrelor for 1 month followed by resumption of conventional DAPT with aspirin and clopidogrel for 11 months would be superior to conventional DAPT for 12 months in reducing the prevalence of HOPR and MACE without increasing bleeding.

Inclusion criteria:

Successively recruit all patients who receive stent implantation;
Intended use of conventional DAPT with the combination of aspirin 100mg once daily and clopidogrel 75mg once daily for at least 12 months;
Patient aged over 18 years;
Signed inform consent.

Exclusion criteria:

Allergy or intolerance to study drugs;
History of gastrointestinal or intracranial bleeding;
Need for anticoagulant therapy;
High risk of bleeding (e.g., myelodysplasia, baseline platelet count < 80 × 109/L);
Hemoglobin < 90g/L;
Active malignancy or life expectancy < 1 year;
Patients with other conditions made them unsuitable to be recruited at the discretion of the investigators.

Study procedures:

Following treatment for at least 5 days with the combination of aspirin 100mg once daily and clopidogrel 75mg once daily irrespective of a loading dose we measured platelet aggregation in response to adenosine diphosphate (ADP) (PLADP) using light transmittance aggregometry (LTA). HOPR was defined as PLADP > 40%. Patients with HOPR were continued on aspirin 100mg once daily and were randomly assigned to one of the following 4 groups:

clopidogrel 150mg once daily (CLOP-150);
clopidogrel 75mg once daily plus cilostazol 100mg twice daily (CLOP+CILOST);
ticagrelor 90mg twice daily (TICAG);
clopidogrel 75mg once daily (conventional DAPT, CON). At 1 month, platelet aggregation testing was repeated after which all patients were switched back to conventional DAPT for a further 11 months.

All patients without HOPR were treated with conventional DAPT and followed to 12 months (Non-HOPR).

Sample size calculation:

Based on the published literature, we assumed a 38% rate of persistent HOPR in patients randomized to intensified treatment and 60% in those randomized to CON therapy. With a sample size of 81 per group, we calculated that we would have 80% power to detect this difference with a 2-sided P value of 0.05. After allowing for 20% study drug discontinuation rate at 1 month, we planned a sample size of 405 patients with HOPR.

Platelet Reactivity Assay

ADP-induced platelet aggregation: Light transmittancy aggregation (LTA) in response to 5μM ADP.
Blood sample collection time: baseline (more than 5 days after taking clopidogrel 75mg daily and aspirin 100mg daily), 1month after randomization.

Clinical follow-up:

Time points: 1month, 6month, and 1year after randomization.

The study endpoints:

The primary outcome was the proportion of patients with persistent HOPR at 1 month.

The secondary outcomes included a composite of MACE including cardiovascular death, nonfatal myocardial infarction (MI), ischemic stroke, target vessel revascularization (TVR), stent thrombosis (ST) and cardiac readmission during 12-month follow-up, and any bleeding defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria.

Conditions: Coronary Artery Disease
Being tested: Clopidogrel, Cilostazol, Ticagrelor
Keywords: Stent implantation, High on-treatment platelet reactivity, Ticagrelor, Cilostazol, Clopidogrel
Medical subject headings: Coronary Artery Disease

What participants receive

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

ClopidogrelDrug
Also called Plavix
(ASA 100mg daily + Clopidogrel 150mg daily) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
CilostazolDrug
Also called Peida
(ASA 100mg daily + Clopidogrel 75mg daily + Cilostazol 150mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
TicagrelorDrug
Also called Brilinta
(ASA 100mg daily + Ticagrelor 90mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
ClopidogrelDrug
Also called Plavix
(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.
ClopidogrelDrug
Also called Plavix
(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.

Study groups in NCT01955200
Study group	Role	What they receive
CLOP-150	Experimental	clopidogrel 150mg once daily Receives: Drug: Clopidogrel
CLOP+CILOST	Experimental	clopidogrel 75mg once daily plus cilostazol 100mg twice daily Receives: Drug: Cilostazol
TICAG	Experimental	ticagrelor 90mg twice daily Receives: Drug: Ticagrelor
CON(conventional DAPT)	Active comparator	clopidogrel 75mg once daily Receives: Drug: Clopidogrel
Non-HOPR	Active comparator	clopidogrel 75mg once daily Receives: Drug: Clopidogrel

What is being measured

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

the proportion of patients with persistent HOPR at 1 month
platelet aggregation in response to 5μM adenosine diphosphate (PLADP) measured by light transmittancy aggregometer (LTA) ; HOPR was defined as PLADP > 40%.
Measured: 1-month after randomization

Secondary outcomes (1)

MACE
a composite of MACE including cardiovascular death, nonfatal myocardial infarction (MI), ischemic stroke, target vessel revascularization (TVR), stent thrombosis (ST) and cardiac readmission during 12-month follow-up,revascularization, and stent thrombosis (ARC definition)
Measured: 1-year after randomization

Timeline

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

5 Oct 201328 Nov 2017

First posted7 Oct 2013 (estimated)
Study start5 Oct 2013
Primary completion26 Dec 2016
Study completion28 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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: 1,724 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01955200
Sponsor's protocol ID: 001
Acronym: OPTIMA-2
Status last verified: Aug 2020
First submitted: 28 Sep 2013
Last updated: 18 Aug 2020
Results posted: No
Data monitoring committee: No

Publications

Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
PubMed 11519503
Main C, Palmer S, Griffin S, Jones L, Orton V, Sculpher M, Henderson R, Sudlow C, Hawkins N, Riemsma R. Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation. Health Technol Assess. 2004 Oct;8(40):iii-iv, xv-xvi, 1-141. doi: 10.3310/hta8400.
PubMed 15461878
Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.
PubMed 16531616
Kronzon I, Feit F. Clopidogrel plus aspirin was effective but increased bleeding in acute coronary syndromes without ST-segment elevation. ACP J Club. 2002 Mar-Apr;136(2):45. doi: 10.7326/ACPJC-2002-136-2-045. No abstract available.
PubMed 11874270
De Miguel A, Ibanez B, Badimon JJ. Clinical implications of clopidogrel resistance. Thromb Haemost. 2008 Aug;100(2):196-203.
PubMed 18690337
Mehta SR, Tanguay JF, Eikelboom JW, Jolly SS, Joyner CD, Granger CB, Faxon DP, Rupprecht HJ, Budaj A, Avezum A, Widimsky P, Steg PG, Bassand JP, Montalescot G, Macaya C, Di Pasquale G, Niemela K, Ajani AE, White HD, Chrolavicius S, Gao P, Fox KA, Yusuf S; CURRENT-OASIS 7 trial investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet. 2010 Oct 9;376(9748):1233-43. doi: 10.1016/S0140-6736(10)61088-4.
PubMed 20817281
Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
PubMed 19717846
Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290.
PubMed 21406646
Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28.
PubMed 28855078
Deharo P, Quilici J, Camoin-Jau L, Johnson TW, Bassez C, Bonnet G, Fernandez M, Ibrahim M, Suchon P, Verdier V, Fourcade L, Morange PE, Bonnet JL, Alessi MC, Cuisset T. Benefit of Switching Dual Antiplatelet Therapy After Acute Coronary Syndrome According to On-Treatment Platelet Reactivity: The TOPIC-VASP Pre-Specified Analysis of the TOPIC Randomized Study. JACC Cardiovasc Interv. 2017 Dec 26;10(24):2560-2570. doi: 10.1016/j.jcin.2017.08.044.
PubMed 29268886
Ying L, Wang J, Li J, Teng J, Zhang X, Ullah I, Samee A, Xu K, Chen J, Xu L, Zhu H, Li J, Yang L, Wang F, Fan Y, Zhang J, Lu Y, Gong X, Shi L, Eikelboom JW, Li C. Intensified antiplatelet therapy in patients after percutaneous coronary intervention with high on-treatment platelet reactivity: the OPTImal Management of Antithrombotic Agents (OPTIMA)-2 Trial. Br J Haematol. 2022 Jan;196(2):424-432. doi: 10.1111/bjh.17847. Epub 2021 Oct 5.
PubMed 34611892
Wang J, Abdus S, Tan C, Gu Q, Yang M, Wang G, Shi L, Gong X, Li C. Serum uric acid level negatively correlated with the prevalence of clopidogrel low response in patients undergoing antiplatelet treatment with aspirin and clopidogrel. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2215-2220. doi: 10.1016/j.numecd.2020.07.025. Epub 2020 Jul 24.
PubMed 32912788

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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intensified Antiplatelet Therapy in Post-PCI Patients With High On-treatment Platelet Reactivity: the OPTIMA-2 Trial
ClinicalTrials.gov ID: NCT01955200
Acronym / sponsor ID: OPTIMA-2 / 001
Conditions: Coronary Artery Disease
Keywords: Stent implantation, High on-treatment platelet reactivity, Ticagrelor, Cilostazol, Clopidogrel
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,724 participants (actual)
Lead sponsor: The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
Collaborators: National Natural Science Foundation of China
Study start: 5 Oct 2013 (actual)
Primary completion: 26 Dec 2016 (actual)
Study completion: 28 Nov 2017 (actual)
First posted: 7 Oct 2013 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

OPTImal Management of Antithrombotic agents: OPTIMA-2 trial

Inclusion criteria:

Successively recruit all patients who receive stent implantation;
Intended use of conventional DAPT with the combination of aspirin 100mg once daily and clopidogrel 75mg once daily for at least 12 months;
Patient aged over 18 years;
Signed inform consent.

Exclusion criteria:

Allergy or intolerance to study drugs;
History of gastrointestinal or intracranial bleeding;
Need for anticoagulant therapy;
High risk of bleeding (e.g., myelodysplasia, baseline platelet count < 80 × 109/L);
Hemoglobin < 90g/L;
Active malignancy or life expectancy < 1 year;
Patients with other conditions made them unsuitable to be recruited at the discretion of the investigators.

Study procedures:

clopidogrel 150mg once daily (CLOP-150);
clopidogrel 75mg once daily plus cilostazol 100mg twice daily (CLOP+CILOST);
ticagrelor 90mg twice daily (TICAG);
clopidogrel 75mg once daily (conventional DAPT, CON). At 1 month, platelet aggregation testing was repeated after which all patients were switched back to conventional DAPT for a further 11 months.

All patients without HOPR were treated with conventional DAPT and followed to 12 months (Non-HOPR).

Sample size calculation:

Platelet Reactivity Assay

ADP-induced platelet aggregation: Light transmittancy aggregation (LTA) in response to 5μM ADP.
Blood sample collection time: baseline (more than 5 days after taking clopidogrel 75mg daily and aspirin 100mg daily), 1month after randomization.

Clinical follow-up:

Time points: 1month, 6month, and 1year after randomization.

The study endpoints:

The primary outcome was the proportion of patients with persistent HOPR at 1 month.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
CLOP-150	Experimental	Drug: Clopidogrelclopidogrel 150mg once daily
CLOP+CILOST	Experimental	Drug: Cilostazolclopidogrel 75mg once daily plus cilostazol 100mg twice daily
TICAG	Experimental	Drug: Ticagrelorticagrelor 90mg twice daily
CON(conventional DAPT)	Active comparator	Drug: Clopidogrelclopidogrel 75mg once daily
Non-HOPR	Active comparator	Drug: Clopidogrelclopidogrel 75mg once daily

Who may qualify

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

Key inclusion criteria (4 listed)

Successively recruit all patients who receive stent implantation;
Intended use of standard DAPT with the combination of aspirin 100mg once daily and clopidogrel 75mg once daily for at least 12 months;
Patient aged >18 years and ≦80 years old;
Signed inform consent.

Key exclusion criteria (7 listed)

Allergy or intolerance to study drugs;
History of gastrointestinal or intracranial bleeding;
Need for anticoagulant therapy;
High risk of bleeding (e.g., myelodysplasia, baseline platelet count < 80 × 109/L);
Hemoglobin < 90g/L;

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
ClopidogrelAlso: Plavix(ASA 100mg daily + Clopidogrel 150mg daily) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.	Drug	CLOP-150
CilostazolAlso: Peida(ASA 100mg daily + Clopidogrel 75mg daily + Cilostazol 150mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.	Drug	CLOP+CILOST
TicagrelorAlso: Brilinta(ASA 100mg daily + Ticagrelor 90mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.	Drug	TICAG
ClopidogrelAlso: Plavix(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.	Drug	CON(conventional DAPT)
ClopidogrelAlso: Plavix(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.	Drug	Non-HOPR

Primary outcome

the proportion of patients with persistent HOPR at 1 month
Time frame: 1-month after randomization
platelet aggregation in response to 5μM adenosine diphosphate (PLADP) measured by light transmittancy aggregometer (LTA) ; HOPR was defined as PLADP > 40%.

1 secondary outcome

MACE
Time frame: 1-year after randomization

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
Background: PubMed 11519503Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. doi: 10.1056/NEJMoa010746.
Background: PubMed 15461878Main C, Palmer S, Griffin S, Jones L, Orton V, Sculpher M, Henderson R, Sudlow C, Hawkins N, Riemsma R. Clopidogrel used in combination with aspirin compared with aspirin alone in the treatment of non-ST-segment-elevation acute coronary syndromes: a systematic review and economic evaluation. Health Technol Assess. 2004 Oct;8(40):iii-iv, xv-xvi, 1-141. doi: 10.3310/hta8400.
Background: PubMed 16531616Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.
Background: PubMed 11874270Kronzon I, Feit F. Clopidogrel plus aspirin was effective but increased bleeding in acute coronary syndromes without ST-segment elevation. ACP J Club. 2002 Mar-Apr;136(2):45. doi: 10.7326/ACPJC-2002-136-2-045. No abstract available.
Background: PubMed 18690337De Miguel A, Ibanez B, Badimon JJ. Clinical implications of clopidogrel resistance. Thromb Haemost. 2008 Aug;100(2):196-203.
Background: PubMed 20817281Mehta SR, Tanguay JF, Eikelboom JW, Jolly SS, Joyner CD, Granger CB, Faxon DP, Rupprecht HJ, Budaj A, Avezum A, Widimsky P, Steg PG, Bassand JP, Montalescot G, Macaya C, Di Pasquale G, Niemela K, Ajani AE, White HD, Chrolavicius S, Gao P, Fox KA, Yusuf S; CURRENT-OASIS 7 trial investigators. Double-dose versus standard-dose clopidogrel and high-dose versus low-dose aspirin in individuals undergoing percutaneous coronary intervention for acute coronary syndromes (CURRENT-OASIS 7): a randomised factorial trial. Lancet. 2010 Oct 9;376(9748):1233-43. doi: 10.1016/S0140-6736(10)61088-4.
Background: PubMed 19717846Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
Background: PubMed 21406646Price MJ, Berger PB, Teirstein PS, Tanguay JF, Angiolillo DJ, Spriggs D, Puri S, Robbins M, Garratt KN, Bertrand OF, Stillabower ME, Aragon JR, Kandzari DE, Stinis CT, Lee MS, Manoukian SV, Cannon CP, Schork NJ, Topol EJ; GRAVITAS Investigators. Standard- vs high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011 Mar 16;305(11):1097-105. doi: 10.1001/jama.2011.290.
Background: PubMed 28855078Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28.
Background: PubMed 29268886Deharo P, Quilici J, Camoin-Jau L, Johnson TW, Bassez C, Bonnet G, Fernandez M, Ibrahim M, Suchon P, Verdier V, Fourcade L, Morange PE, Bonnet JL, Alessi MC, Cuisset T. Benefit of Switching Dual Antiplatelet Therapy After Acute Coronary Syndrome According to On-Treatment Platelet Reactivity: The TOPIC-VASP Pre-Specified Analysis of the TOPIC Randomized Study. JACC Cardiovasc Interv. 2017 Dec 26;10(24):2560-2570. doi: 10.1016/j.jcin.2017.08.044.
Derived from this study: PubMed 34611892Ying L, Wang J, Li J, Teng J, Zhang X, Ullah I, Samee A, Xu K, Chen J, Xu L, Zhu H, Li J, Yang L, Wang F, Fan Y, Zhang J, Lu Y, Gong X, Shi L, Eikelboom JW, Li C. Intensified antiplatelet therapy in patients after percutaneous coronary intervention with high on-treatment platelet reactivity: the OPTImal Management of Antithrombotic Agents (OPTIMA)-2 Trial. Br J Haematol. 2022 Jan;196(2):424-432. doi: 10.1111/bjh.17847. Epub 2021 Oct 5.
Derived from this study: PubMed 32912788Wang J, Abdus S, Tan C, Gu Q, Yang M, Wang G, Shi L, Gong X, Li C. Serum uric acid level negatively correlated with the prevalence of clopidogrel low response in patients undergoing antiplatelet treatment with aspirin and clopidogrel. Nutr Metab Cardiovasc Dis. 2020 Nov 27;30(12):2215-2220. doi: 10.1016/j.numecd.2020.07.025. Epub 2020 Jul 24.

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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.

Chunjian Li, Ph.D principal investigator

The First Affiliated Hospital with Nanjing Medical University

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Clopidogrel, Cilostazol and Ticagrelor in people with Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

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 4 inclusion and 7 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 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

the proportion of patients with persistent HOPR at 1 month (time frame: 1-month after randomization). 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 NCT01955200, which also lists 12 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 18 Aug 2020.