Mono- Versus Dual antiPlatelet Therapy During 6-12 Months After New Generation Drug Eluting Stent Implantation

NCT03198741 | Completed Phase 4 DMC

• 1 other identifier: SYNH-20170602
• Study Type: interventional
• Target: 783
• Locations: 1 country
• Sites: 1

Brief Summary

Long-term DAPT is recommended after percutaneous coronary intervention (PCI) in patients with coronary artery disease. However, antiplatelet therapy may have adverse consequences, the most common of which is gastrointestinal mucosal injury with ulceration and bleeding. The extent to which an an abbreviated DAPT strategy reduces gastrointestinal mucosal injury has not been studied, principally due to the lack of sensitive, noninvasive measurements capable of detecting gastrointestinal injury.ANKON® magnetically controlled capsule endoscopy (AMCE) is a non-invasive, active controlled system which affords assessment of the stomach and entire small intestine.The current randomized study will assess gastrointestinal mucosal injury and bleeding via AMCE in patients on three different antiplatelet regimens and establish a gastrointestinal mucosal injury scoring system which may prove useful in guiding optimal antiplatelet agent usage after PCI.

Conditions

Gastrointestinal Injury; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Gastrointestinal mucosal Injury (erosion, ulceration or bleeding)

  Detected by AMCE

  12 months after enrollment (i.e. 6 months after randomization)

Secondary Outcomes (10)

• The severity of gastric and intestinal mucosal lesions

  During the first 6 months after study enrollment (prior to randomization)

• The severity of gastric and intestinal mucosal lesions

  After randomization (i.e. between 6 months and 12 months after study enrollment)

• Clinical indicated bleeding of the upper gastrointestinal tract

  During 6 months after study enrollment (prior to randomization)

• Clinical indicated evident gastrointestinal hemorrhage

  After randomization (i.e. between 6 months and 12 months after study enrollment)

• Clinical indicated gastrointestinal hemorrhage

  12 months after enrollment (i.e. 6 months after randomization)

Study Arms (3)

Aspirin+clopidogrel

ACTIVE COMPARATOR

Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),continue aspirin + clopidogrel (12-month DAPT group).The treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks).

Drug: Aspirin + clopidogrel

Aspirin

EXPERIMENTAL

Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive aspirin + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks).

Drug: Aspirin monotherapy

Clopidogrel

EXPERIMENTAL

Open label clopidogrel (75mg/d) plus aspirin (100mg/d) for first 6 months after enrollment. At 6 months (±2 weeks),receive clopidogrel + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded. Evaluation of gastric and intestinal mucosal lesions by AMCE will be performed at the time of screening, randomization (at 6 months ±2 weeks) and 6 months thereafter (at 12 months ±2 weeks).

Drug: Clopidogrel monotherapy

Interventions

Aspirin + clopidogrel DRUG

After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + clopidogrel 75mg/d for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.

Aspirin+clopidogrel

Clopidogrel monotherapy DRUG

After randomization(6 months±2 weeks after enrollment),receive clopidogrel 75mg/d + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.

Also known as: Clopidogrel + placebo

Clopidogrel

Aspirin monotherapy DRUG

After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.

Also known as: Aspirin + clopidogrel

Aspirin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with age of 18-80 years;
• Presentation with silent ischemia, stable angina, or non-ST-segment elevation acute coronary syndrome with GRACE score \<140 on admission;
• PCI only with implantation of current generation drug-eluting stent(s) for coronary artery disease during the present admission \[current generation DES refers to DES with thin cobalt-chromium or platinum-chromium struts, with a durable or biodegradable polymer eluting a rapamycin-analogue antiproliferative agent. The current major DES available in China market include: EXCEL and EXCEL 2 (JW Medical System, Weihai, China), Tivoli（Essen Technology, Beijing, China), Endeavor Resolute (Medtronic Inc., Minnesota, USA), FireHawk (MicroPort Medical (Group) Co., Ltd, Shanghai, China), BuMA (SinoMedical,China),Xience V (Abbott Laboratories, Abbott Park, Illinois, USA), Xience Prime (Abbott Laboratories, Abbott Park, Illinois, USA), Promus Element and Synergy (BostonTechnologies, Massachusetts, USA)\].
• PCI resulted in complete revascularization (successful PCI treatment of all epicardial coronary lesions with diameter stenosis \>70% or intermediate lesions with FFR ≤0.80);
• Intended treatment with dual antiplatelet therapy (aspirin + clopidogrel) after the DES procedure for at least 6 months;
• Agreement to comply with all study procedures.
• Written informed consent provided.

You may not qualify if:

• Presentation with STEMI;
• Left main disease (diameter stenosis \>30% );
• Any prior coronary stent implantation during the last year prior to the index procedure;
• Implantation of of first-generation drug-eluting stents or bioabsorbable scaffolds during the index procedure;
• Implantation of \>4 stents during the index procedure;
• Any prior stent thrombosis;
• Any active gastrointestinal bleeding or ulcers, or prior gastrointestinal bleeding or ulcers within the last 24 months;
• Prior gastrointestinal tract or abdominal surgery other than simple procedures which would not change the gastrointestinal tract anatomy, such as polyp removal, cholecystectomy or appendectomy;
• Contraindications to the AMCE test, including suspected or known gastrointestinal obstruction, stenosis, fistula, diverticula, etc.; presence of gastrointestinal obstruction symptoms such as pain or dysphagia; inoperative conditions or refusal to undergo abdominal surgery if required (i.e, if the capsule will not pass and cannot be removed by endoscopy)
• Severe hemorrhoids (phase 3-4 according to guidelines of American Society of Colon and Rectal Surgery);
• LVEF \<0.40 on admission according to cardiac ultrasound;
• Renal dysfunction (eGFR \<30ml/min/1.73m2);
• Active hepatitis or ALT \>3 times upper limits of normal on admission;
• Uncontrolled severe hypertension (\>180/110mmHg);
• Hemoglobin \<100 g/L;

Sponsors & Collaborators

• Shenyang Northern Hospital: lead
• Changhai Hospital: collaborator
• ANKON medical technologies (Shanghai)Co.,LTD: collaborator

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 110016, China

Location

Related Publications (3)

• Li Y, Wang X, Bao D, Liao Z, Li J, Han X, Wang H, Xu K, Li Z, Stone GW, Han Y. Optimal antiplatelet therapy for prevention of gastrointestinal injury evaluated by ANKON magnetically controlled capsule endoscopy: Rationale and design of the OPT-PEACE trial. Am Heart J. 2020 Oct;228:8-16. doi: 10.1016/j.ahj.2020.06.004. Epub 2020 Jun 15.

  PMID: 32745734 BACKGROUND

• Han Y, Liao Z, Li Y, Zhao X, Ma S, Bao D, Qiu M, Deng J, Wang J, Qu P, Jiang C, Jia S, Yang S, Ru L, Feng J, Gao W, Huang Y, Tao L, Han Y, Yang K, Wang X, Zhang W, Wang B, Li Y, Yang Y, Li J, Sheng J, Ma Y, Cui M, Ma S, Wang X, Li Z, Stone GW. Magnetically Controlled Capsule Endoscopy for Assessment of Antiplatelet Therapy-Induced Gastrointestinal Injury. J Am Coll Cardiol. 2022 Jan 18;79(2):116-128. doi: 10.1016/j.jacc.2021.10.028. Epub 2021 Nov 6.

  PMID: 34752902 BACKGROUND

• He C, Li Y, Jiang X, Jiang MN, Zhao XX, Ma SR, Bao D, Qiu MH, Deng J, Wang JH, Qu P, Jiang CM, Jia SB, Yang SQ, Ru LS, Feng J, Gao W, Huang YH, Tao L, Han Y, Yang K, Wang XY, Zhang WJ, Wang BM, Li Y, Yang YL, Li JX, Sheng JQ, Ma YT, Cui M, Ma SC, Wang XZ, Li ZS, Liao Z, Han YL, Stone GW. Progression of Gastrointestinal Injury During Antiplatelet Therapy After Percutaneous Coronary Intervention: A Secondary Analysis of the OPT-PEACE Randomized Clinical Trial. JAMA Netw Open. 2023 Nov 1;6(11):e2343219. doi: 10.1001/jamanetworkopen.2023.43219.

  PMID: 37976067 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yaling Han, PhD

  General Hospital of Shenyang Military Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Cardiology department

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 26, 2017
• Study Start: July 13, 2017
• Primary Completion: August 13, 2020
• Study Completion: August 13, 2020
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)